Colo-rectal CancerNCT04585516
Diagnostic Usefulness of Different Types of Gastrointestinal Endoscopic Investigations.
An observational study of Colo-rectal Cancer and Gastrointestinal Disease, run by Region Örebro County at 1 site in Sweden.
Trial summary
The number of endoscopies performed varies greatly between different countries and does not reflect variations in disease incidents. The costs of unnecessary endoscopies are significant and with a better selection of which patients need to be examined with endoscopy, resources could be saved in healthcare, and a… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colo-rectal Cancer, Gastrointestinal Disease
- What is being tested?
- endoscopy
- Type of treatment
- Surgery or procedure
- How many people
- 5,000 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jan 2020to Jan 2028
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who underwent an endoscopic diagnostic procedure.
Who may be able to join
- All patients who underwent a diagnostic diagnostic procedure at the endoscopy unit at the University Hospital Örebro.
Who cannot join
- Patients <18 years
Trial locations and contacts
1 site in 1 country.
About this study
The number of endoscopies performed varies greatly between different countries and does not reflect variations in disease incidents. The costs of unnecessary endoscopies are significant and with a better selection of which patients need to be examined with endoscopy, resources could be saved in healthcare, and a better triage would mean that malignancies and other more serious conditions do not have to wait. An example of unnecessary endoscopy is a colonoscopy in patients with irritable bowel syndrome or gastroscopy in patients with functional dyspepsia.
The purpose of the project is, among other things:
- What diagnostic benefit have gastroscopy, colonoscopy, capsule endoscopy and double balloon enteroscopy for different indications in different age groups?
- What are the risks of this type of examination?
- Can patients be better selected based on symptoms, psychometric data or laboratory findings to reduce the number of unnecessary examinations and prioritize those that should be scooped up first?
- Can changed calling methods reduce the number of late cancellations and rebookings and missed patients?
Read the detailed description
1: Identification of colorectal cancer in Örebro Region - Effectiveness of Standardised Course of Care.
Introduction: To shorten time to diagnosis of suspected colorectal cancer (CRC) in Sweden, CRC was included in the "standardised course of care" (SCC) in 2016. However, not all patients with CRC are referred via the SCC, and CRC is also found in patients undergoing a routine colonoscopy.
Objective: To identify CRC cases in the Örebro Region and how they were identified. Furthermore, to investigate the reasons for and possible effect of not being included in the SCC-CRC for cases found via colonoscopy.
Methods: Reviewing medical records of patients with CRC referred to the Clinic of Surgery in the Örebro Region in 2016-2018 (n=459).
The information recalled from the journals includes diagnostic pathway of CRC discovery, age, gender, Body Mass Index (BMI), Hb-value, date of referral to colonoscopy, date of preformed colonoscopy, referral route (SCC-CRC or non-CRC-SCC), reasons for referral (including SCC-CRC criteria) and patient symptoms. Furthermore, we will gather data of tumor localization (caecum; ascending colon; splenic flexure; transverse colon; hepatic flexure; descending colon; sigmoid and rectum), TNM-stage of the tumor, [11] tumor differentiation (high grade or low grade tumor), and source of referral (referral by general practitioner or referral by hospital physician).
Age is determined at the time of referral. BMI is defined as the most recent BMI value at time of referral within six months prior or six months after referral date. Hb-value will be defined as the most recent Hb-value within a month prior of the time of referral. Diagnostic interval is defined as the number of days days between the referral and the colonoscopy. When the tumor localization is described as in between two locations of the colon (e.g. descendent colon and sigmoid colon) the most proximal location is chosen for statistical analysis. Patients with two or more synchronous cancers are registered as more than one incident per case. When the tumor localization is described as being present in the rectosigmoid transition, the sigmoid is used as the tumor localization in the analysis. When patients have two or more symptoms and reasons for referral, data are registered as more than one incident per case. TNM stage is converted to tumor stage I-IV. [1] When patients have one or more synchronic cancer with different TNM stages, the highest cancer stage is chosen for analysis. If the TNM stage is not fully known (e.g. information about lymph nodes and metastases are missing) the stage is set as no lymph node engagement or metastases, If the original referral cannot be found, date and reasons for referral are collected from journal entries.
2: The Swedish standardized course of care for colorectal cancer - cancer prevalence and predictive values of entry criteria.
Introduction: To shorten waiting times for cancer treatment and to reduce national inequalities in cancer care, the standardized course of care (SCC) was implemented in Sweden. The SCC for colorectal cancer (CRC-SCC) was implemented in 2016. Since then, about 46.000 patients have been examined according to a CRC-SCC. However, few studies have been conducted to evaluate the CRC-SCC.
Aim: To identify the prevalence of colorectal cancer (CRC) in patients referred to Örebro University Hospital (USÖ) according to a CRC-SCC. We also aimed to investigate the positive predicting values (PPVs) and odds ratios (ORs) of different SCC-criteria with respect to CRC.
Method: Medical record review including all patients examined by colonoscopy as part of a CRC-SCC-referral to USÖ between September, 2016 and December 2018 (n=1271).The parameters of interest include; patient characteristics such as sex and age, the SCC-criteria for reasonable suspicion of cancer. If the patient has an altered bowel function it is registered whether the patient has loose stool, constipation, a combination of the two, or not specified in the referral. Rectal bleeding is defined as fresh rectal bleeding, excluding melaena. Patients who fulfill multiple criteria are registered as more than one incidence case. Laboratory values such as fecal occult blood, plasma-hemoglobin, and fecal-calprotectin (F-calprotectin) are registered. The most resent value at the time of referral is used. If there is no value within a month of the referral, no value was registered. A patient is regarded to have a positive fecal occult blood test (FOBT) if at least one out of three tests is positive. A f-calprotectin <50mg/kg is considered negative. Findings from the colonoscopy such as CRC, polyps, inflammation of the colon, diverticulosis, hemorrhoids, angiodysplasia or no finding are registered. All findings with colonoscopy are, if possible, histologically verified.
3: Why do we perform gastroscopy in younger patients?
Background: Esophagogastroduodenoscopy (EGD) is the golden standard diagnostic method in upper GI pathologies. The current guidelines indicate that patients with alarm symptoms and/or dyspeptic patients over 50 years of age should be readily investigated with gastroscopy. However, EGD is also frequently performed in the younger population, where it often results in absence of pathological findings. In Örebro approximately 4000 EGD are completed yearly, approximately 40% of the EGD's are performed in patients >50 years, requiring extensive resources.
Aim: to identify factors in the EGD referrals of patients under 50 years of age without alarm symptoms, in order to minimize the number of unnecessary EGD's in this age group.
Method and material: The study will be conducted as a retrospective database study. We will process the EGD referrals and diagnostic findings of young patients (age 18-50 y) performed during 2017-2019 at Örebro University Hospital. Statistical analysis will be performed to identify which signs and symptoms are associated with a pathological finding during EGD and which signs and symptoms are associated with a negative finding. The parameters of interest include; patient characteristics such as sex and age will separately analyze the groups 18-29y, 30-39y, and 40-49 y. Other parameters include: BMI, ethnicity, use of NSAID/ASA, h. pylori analysis, eventual treatment for h. pylori, smoking, alcohol consumption,presence of GI disease before gastroscopy, previously done gastroscopy, source of referral (primary health care or in-hospital patients), if present: fulfillment of Rome IV criteria for functional dyspepsia, symptoms such as anemia, fecal occult blood, palpable mass in abdomen, weight loss, loss of appetite, dysphagia, vomiting, jaundice, waiting time between referral and gastroscopy, as well as the findings under gastroscopy; GERD/oesofagitis, peptic ulcus, gastritis, dysplasia/cancer, IBD, celiac disease, hiatal hernia
- Conditions
- Colo-rectal Cancer, Gastrointestinal Disease
- Being tested
- endoscopy
- Keywords
- colonoscopy, gastroscopy
- Medical subject headings
- Colonic Neoplasms, Gastrointestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endoscopyProcedure or surgery
Colonoscopy or gastroscopy
| Study group | Role | What they receive |
|---|---|---|
| Patient with suspected colorectal cancer | All patients that were admitted to the department of surgery with suspected colorectal cancer between January 2016 and December 2018 (n=459). Receives: Procedure: endoscopy | |
| Patients admitted according to the standardized course of care for colorectal cancer | All patients that were admitted to the endoscopy department according to the standardized course of care for colorectal cancer between September 2016 and December 2018 (n=1271). Receives: Procedure: endoscopy | |
| Patients < 50 years that were admitted for gastroscopy | All patients younger than 50 years that were admitted to the endoscopy department for a gastroscopy between jan 2018 and April 2019 (n= 1915) Receives: Procedure: endoscopy | |
| Patients >80 years that were admitted for colonoscopy | All patients older than 80 years that were admitted to the endoscopy department for a colonoscopy between Sept 2016 and Jan 2019 (n= 981) Receives: Procedure: endoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
All confirmed colorectal cancer cases that were diagnosed via colonoscopy.
The proportion of patients that was admitted to the department of surgery with confirmed colorectal cancer, diagnosed according to the standardized course of care for colorectal cancer.
Measured: between September 2016 and December 2018
Proportion of patients that was diagnosed with colorectal cancer. with colorectal cancer
All patients that were admitted to the endoscopy unit according to the standardized course of care for colorectal cancer.
Measured: between September 2016 and December 2018
Presence of upper GI pathology
The proportion of upper GI pathology in all patients <50 years who were admitted for a gastroscopy
Measured: between Jan 2019-April 2020
Secondary outcomes (19)
route of colorectal cancer diagnosis 1
The proportion of patients with confirmed colorectal cancer that was diagnosed with colonoscopy according to the standardized chain of care for colorectal cancer.
Measured: January 2016 and December 2018
route of colorectal cancer diagnosis 2
The proportion of patients with confirmed colorectal cancer that was diagnosed with routine colonoscopy.
Measured: January 2016 and December 2018
Localization of colorectal cancer
The site of the tumor in confirmed colorectal cancer
Measured: January 2016 and December 2018
tumor characteristics of colorectal cancer 1
The stage of the tumor in confirmed colorectal cancer
Measured: January 2016 and December 2018
tumor characteristics of colorectal cancer 2
The histology of the tumor in confirmed colorectal cancer
Measured: January 2016 and December 2018
symptom characteristics of colorectal cancer 1
proportion of patients with changes in bowel habits >4 weeks in patients with confirmed colorectal cancer
Measured: January 2016 and December 2018
symptom characteristics of colorectal cancer 2
proportion of patients with radiology in patients with confirmed colorectal cancer
Measured: January 2016 and December 2018
symptom characteristics of colorectal cancer 3
proportion of patients with abnormal rectal finding via palpation or rectoscopy in patients with confirmed colorectal cancer
Measured: January 2016 and December 2018
symptom characteristics of colorectal cancer 4
proportion of patients with rectal bleeding without obvious source in patients with confirmed colorectal cancer
Measured: January 2016 and December 2018
symptom characteristics of colorectal cancer 5
proportion of patients with rectal bleeding despite adequate treatment of bleeding source in patients with confirmed colorectal cancer
Measured: January 2016 and December 2018
symptom characteristics of colorectal cancer 6
proportion of patients with rectal bleeding in high-risk patients with confirmed colorectal cancer
Measured: January 2016 and December 2018
symptom characteristics of colorectal cancer 7
proportion of patients with bleeding anemia of unknown source in patients with confirmed colorectal cancer
Measured: January 2016 and December 2018
patient characteristics of colorectal cancer 1
male/female
Measured: January 2016 and December 2018
patient characteristics of colorectal cancer 2
age
Measured: January 2016 and December 2018
patient characteristics of colorectal cancer 3
hemoglobine value
Measured: January 2016 and December 2018
patient characteristics of colorectal cancer 4
calprotectin value
Measured: January 2016 and December 2018
patient characteristics of colorectal cancer 5
Days between referral and colonoscopy
Measured: January 2016 and December 2018
patient characteristics of colorectal cancer 6
referral from primary health care yes/no
Measured: January 2016 and December 2018
patient characteristics of colorectal cancer 7
referral year: 2017/2017/2018
Measured: January 2016 - December 2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2020
- Study start1 Jan 2020
- Primary completionJan 2028 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Colo-rectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 5,000 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Region Örebro County
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michiel van Nieuwenhoven, Region Örebro County
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04585516
- Sponsor's protocol ID
- 274964
- Status last verified
- Oct 2020
- First submitted
- 7 Oct 2020
- Last updated
- 14 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nguyen L, Rasanen N, Berggren F, van Nieuwenhoven MA. Assessing age-related risks of gastrointestinal pathologies: a comparative study of gastroscopy outcomes across decades. Ther Adv Gastroenterol. 2024 Oct 28;17:17562848241290446. doi: 10.1177/17562848241290446. eCollection 2024.
PubMed 39474441Andersson E, Nyhlin N, van Nieuwenhoven MA. The effectiveness of the colorectal cancer referral pathway - identification of colorectal cancer in a Swedish region. Scand J Gastroenterol. 2021 May;56(5):552-558. doi: 10.1080/00365521.2021.1899276. Epub 2021 Mar 22.
PubMed 33749502
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Usefulness of Different Types of Gastrointestinal Endoscopic Investigations.
- ClinicalTrials.gov ID
- NCT04585516
- Acronym / sponsor ID
- 274964
- Conditions
- Colo-rectal Cancer, Gastrointestinal Disease
- Keywords
- colonoscopy, gastroscopy
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Region Örebro CountyUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 14 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The number of endoscopies performed varies greatly between different countries and does not reflect variations in disease incidents. The costs of unnecessary endoscopies are significant and with a better selection of which patients need to be examined with endoscopy, resources could be saved in healthcare, and a better triage would mean that malignancies and other more serious conditions do not have to wait. An example of unnecessary endoscopy is a colonoscopy in patients with irritable bowel syndrome or gastroscopy in patients with functional dyspepsia.
The purpose of the project is, among other things:
- What diagnostic benefit have gastroscopy, colonoscopy, capsule endoscopy and double balloon enteroscopy for different indications in different age groups?
- What are the risks of this type of examination?
- Can patients be better selected based on symptoms, psychometric data or laboratory findings to reduce the number of unnecessary examinations and prioritize those that should be scooped up first?
- Can changed calling methods reduce the number of late cancellations and rebookings and missed patients?
Detailed description
1: Identification of colorectal cancer in Örebro Region - Effectiveness of Standardised Course of Care.
Introduction: To shorten time to diagnosis of suspected colorectal cancer (CRC) in Sweden, CRC was included in the "standardised course of care" (SCC) in 2016. However, not all patients with CRC are referred via the SCC, and CRC is also found in patients undergoing a routine colonoscopy.
Objective: To identify CRC cases in the Örebro Region and how they were identified. Furthermore, to investigate the reasons for and possible effect of not being included in the SCC-CRC for cases found via colonoscopy.
Methods: Reviewing medical records of patients with CRC referred to the Clinic of Surgery in the Örebro Region in 2016-2018 (n=459).
The information recalled from the journals includes diagnostic pathway of CRC discovery, age, gender, Body Mass Index (BMI), Hb-value, date of referral to colonoscopy, date of preformed colonoscopy, referral route (SCC-CRC or non-CRC-SCC), reasons for referral (including SCC-CRC criteria) and patient symptoms. Furthermore, we will gather data of tumor localization (caecum; ascending colon; splenic flexure; transverse colon; hepatic flexure; descending colon; sigmoid and rectum), TNM-stage of the tumor, [11] tumor differentiation (high grade or low grade tumor), and source of referral (referral by general practitioner or referral by hospital physician).
Age is determined at the time of referral. BMI is defined as the most recent BMI value at time of referral within six months prior or six months after referral date. Hb-value will be defined as the most recent Hb-value within a month prior of the time of referral. Diagnostic interval is defined as the number of days days between the referral and the colonoscopy. When the tumor localization is described as in between two locations of the colon (e.g. descendent colon and sigmoid colon) the most proximal location is chosen for statistical analysis. Patients with two or more synchronous cancers are registered as more than one incident per case. When the tumor localization is described as being present in the rectosigmoid transition, the sigmoid is used as the tumor localization in the analysis. When patients have two or more symptoms and reasons for referral, data are registered as more than one incident per case. TNM stage is converted to tumor stage I-IV. [1] When patients have one or more synchronic cancer with different TNM stages, the highest cancer stage is chosen for analysis. If the TNM stage is not fully known (e.g. information about lymph nodes and metastases are missing) the stage is set as no lymph node engagement or metastases, If the original referral cannot be found, date and reasons for referral are collected from journal entries.
2: The Swedish standardized course of care for colorectal cancer - cancer prevalence and predictive values of entry criteria.
Introduction: To shorten waiting times for cancer treatment and to reduce national inequalities in cancer care, the standardized course of care (SCC) was implemented in Sweden. The SCC for colorectal cancer (CRC-SCC) was implemented in 2016. Since then, about 46.000 patients have been examined according to a CRC-SCC. However, few studies have been conducted to evaluate the CRC-SCC.
Aim: To identify the prevalence of colorectal cancer (CRC) in patients referred to Örebro University Hospital (USÖ) according to a CRC-SCC. We also aimed to investigate the positive predicting values (PPVs) and odds ratios (ORs) of different SCC-criteria with respect to CRC.
Method: Medical record review including all patients examined by colonoscopy as part of a CRC-SCC-referral to USÖ between September, 2016 and December 2018 (n=1271).The parameters of interest include; patient characteristics such as sex and age, the SCC-criteria for reasonable suspicion of cancer. If the patient has an altered bowel function it is registered whether the patient has loose stool, constipation, a combination of the two, or not specified in the referral. Rectal bleeding is defined as fresh rectal bleeding, excluding melaena. Patients who fulfill multiple criteria are registered as more than one incidence case. Laboratory values such as fecal occult blood, plasma-hemoglobin, and fecal-calprotectin (F-calprotectin) are registered. The most resent value at the time of referral is used. If there is no value within a month of the referral, no value was registered. A patient is regarded to have a positive fecal occult blood test (FOBT) if at least one out of three tests is positive. A f-calprotectin <50mg/kg is considered negative. Findings from the colonoscopy such as CRC, polyps, inflammation of the colon, diverticulosis, hemorrhoids, angiodysplasia or no finding are registered. All findings with colonoscopy are, if possible, histologically verified.
3: Why do we perform gastroscopy in younger patients?
Background: Esophagogastroduodenoscopy (EGD) is the golden standard diagnostic method in upper GI pathologies. The current guidelines indicate that patients with alarm symptoms and/or dyspeptic patients over 50 years of age should be readily investigated with gastroscopy. However, EGD is also frequently performed in the younger population, where it often results in absence of pathological findings. In Örebro approximately 4000 EGD are completed yearly, approximately 40% of the EGD's are performed in patients >50 years, requiring extensive resources.
Aim: to identify factors in the EGD referrals of patients under 50 years of age without alarm symptoms, in order to minimize the number of unnecessary EGD's in this age group.
Method and material: The study will be conducted as a retrospective database study. We will process the EGD referrals and diagnostic findings of young patients (age 18-50 y) performed during 2017-2019 at Örebro University Hospital. Statistical analysis will be performed to identify which signs and symptoms are associated with a pathological finding during EGD and which signs and symptoms are associated with a negative finding. The parameters of interest include; patient characteristics such as sex and age will separately analyze the groups 18-29y, 30-39y, and 40-49 y. Other parameters include: BMI, ethnicity, use of NSAID/ASA, h. pylori analysis, eventual treatment for h. pylori, smoking, alcohol consumption,presence of GI disease before gastroscopy, previously done gastroscopy, source of referral (primary health care or in-hospital patients), if present: fulfillment of Rome IV criteria for functional dyspepsia, symptoms such as anemia, fecal occult blood, palpable mass in abdomen, weight loss, loss of appetite, dysphagia, vomiting, jaundice, waiting time between referral and gastroscopy, as well as the findings under gastroscopy; GERD/oesofagitis, peptic ulcus, gastritis, dysplasia/cancer, IBD, celiac disease, hiatal hernia
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 1 Year
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Patient with suspected colorectal cancer | – | Procedure: endoscopyAll patients that were admitted to the department of surgery with suspected colorectal cancer between January 2016 and December 2018 (n=459). |
| Patients admitted according to the standardized course of care for colorectal cancer | – | Procedure: endoscopyAll patients that were admitted to the endoscopy department according to the standardized course of care for colorectal cancer between September 2016 and December 2018 (n=1271). |
| Patients < 50 years that were admitted for gastroscopy | – | Procedure: endoscopyAll patients younger than 50 years that were admitted to the endoscopy department for a gastroscopy between jan 2018 and April 2019 (n= 1915) |
| Patients >80 years that were admitted for colonoscopy | – | Procedure: endoscopyAll patients older than 80 years that were admitted to the endoscopy department for a colonoscopy between Sept 2016 and Jan 2019 (n= 981) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent an endoscopic diagnostic procedure.
Key inclusion criteria (1 listed)
- All patients who underwent a diagnostic diagnostic procedure at the endoscopy unit at the University Hospital Örebro.
Key exclusion criteria (1 listed)
- Patients <18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| endoscopyColonoscopy or gastroscopy | Procedure or surgery | Patient with suspected colorectal cancer, Patients < 50 years that were admitted for gastroscopy, Patients >80 years that were admitted for colonoscopy, Patients admitted according to the standardized course of care for colorectal cancer |
Primary outcome
All confirmed colorectal cancer cases that were diagnosed via colonoscopy.
Time frame: between September 2016 and December 2018
The proportion of patients that was admitted to the department of surgery with confirmed colorectal cancer, diagnosed according to the standardized course of care for colorectal cancer.
Proportion of patients that was diagnosed with colorectal cancer. with colorectal cancer
Time frame: between September 2016 and December 2018
All patients that were admitted to the endoscopy unit according to the standardized course of care for colorectal cancer.
Presence of upper GI pathology
Time frame: between Jan 2019-April 2020
The proportion of upper GI pathology in all patients <50 years who were admitted for a gastroscopy
19 secondary outcomes
route of colorectal cancer diagnosis 1
Time frame: January 2016 and December 2018
route of colorectal cancer diagnosis 2
Time frame: January 2016 and December 2018
Localization of colorectal cancer
Time frame: January 2016 and December 2018
tumor characteristics of colorectal cancer 1
Time frame: January 2016 and December 2018
tumor characteristics of colorectal cancer 2
Time frame: January 2016 and December 2018
symptom characteristics of colorectal cancer 1
Time frame: January 2016 and December 2018
symptom characteristics of colorectal cancer 2
Time frame: January 2016 and December 2018
symptom characteristics of colorectal cancer 3
Time frame: January 2016 and December 2018
symptom characteristics of colorectal cancer 4
Time frame: January 2016 and December 2018
symptom characteristics of colorectal cancer 5
Time frame: January 2016 and December 2018
symptom characteristics of colorectal cancer 6
Time frame: January 2016 and December 2018
symptom characteristics of colorectal cancer 7
Time frame: January 2016 and December 2018
patient characteristics of colorectal cancer 1
Time frame: January 2016 and December 2018
patient characteristics of colorectal cancer 2
Time frame: January 2016 and December 2018
patient characteristics of colorectal cancer 3
Time frame: January 2016 and December 2018
patient characteristics of colorectal cancer 4
Time frame: January 2016 and December 2018
patient characteristics of colorectal cancer 5
Time frame: January 2016 and December 2018
patient characteristics of colorectal cancer 6
Time frame: January 2016 and December 2018
patient characteristics of colorectal cancer 7
Time frame: January 2016 - December 2018
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2020.
- Derived from this study: PubMed 39474441Nguyen L, Rasanen N, Berggren F, van Nieuwenhoven MA. Assessing age-related risks of gastrointestinal pathologies: a comparative study of gastroscopy outcomes across decades. Ther Adv Gastroenterol. 2024 Oct 28;17:17562848241290446. doi: 10.1177/17562848241290446. eCollection 2024.
- Derived from this study: PubMed 33749502Andersson E, Nyhlin N, van Nieuwenhoven MA. The effectiveness of the colorectal cancer referral pathway - identification of colorectal cancer in a Swedish region. Scand J Gastroenterol. 2021 May;56(5):552-558. doi: 10.1080/00365521.2021.1899276. Epub 2021 Mar 22.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colo-rectal Cancer and Gastrointestinal Disease, run by Region Örebro County at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 14 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All confirmed colorectal cancer cases that were diagnosed via colonoscopy. (time frame: between September 2016 and December 2018). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04585516, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2020.