Digestive CancersRETUDNCT06711211
Spanish Registry of Digestive Tumours RETUD
An observational study of Digestive Cancers and Bile Duct Cancer, run by Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD) at 1 site in Spain.
Trial summary
The aim of this observational study is to assess the current state of digestive tumours in Spain. By doing so, it seeks to enhance the quality of care, optimize the diagnosis and treatment of digestive tumours, and identify opportunities for improvement that can benefit patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Digestive Cancers, Bile Duct Cancer, Hepatocellular Cancer (HCC)
- How many people
- 20,000 participants
- Where
- 1 siteSpain
- Study dates
- 23 Dec 2020to Dec 2030
- How long will I take part?
- 10 Years
- 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 diagnosed with digestive tumours in healthcare centres of Spain.
Who may be able to join
- Male and female patients ≥18 years old diagnosed with oesophageal cancer, gastric cancer, pancreatic cancer, hepatocarcinoma, gallbladder and bile duct cancer, cancer of the small intestine, appendix and gastrointestinal stroma, colorectal cancer, anal canal cancer or digestive hereditary cancer.
- Written informed consent available.
Who cannot join
- Patient for whom, for whatever reason, it is not possible to know or obtain the information necessary to complete the data collection base.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Grupo de Tratamiento de los Tumores Digestivos (TTD)
Madrid, Madrid, 28007
About this study
Official title: A Descriptive, Multicentre, Observational Epidemiological Study on Digestive Tumours
The aim of this observational study is to assess the current state of digestive tumours in Spain. By doing so, it seeks to enhance the quality of care, optimize the diagnosis and treatment of digestive tumours, and identify opportunities for improvement that can benefit patients.
The study will investigate the epidemiological, biological, and clinical characteristics of digestive tumors diagnosed in patients aged 18 and older across healthcare centres in Spain. It also aims to generate knowledge and scientific evidence for events and situations that may impact on patients with digestive tumours (e.g. COVID-19 coronavirus pandemic).
Furthermore, subject to the patient's consent, biological samples may be collected for use in translational research projects and for the identification of molecular markers that may be useful in healthcare decision-making.
Read the detailed description
Data will be collected ambispectively, recording those patients who were diagnosed with digestive tumours before the start of the study (from 2017) and also those who are diagnosed after the start of the study.
- Conditions
- Digestive Cancers, Bile Duct Cancer, Hepatocellular Cancer (HCC), Colorectal Cancer (CRC), Pancreatic Cancer, Rectal Cancer
- Keywords
- digestive, cancer, tumours, cholangiocarcinoma, hepatocellular, colorectal, pancreas, rectal
- Medical subject headings
- Gastrointestinal Neoplasms, Bile Duct Neoplasms, Liver Neoplasms, Colorectal Neoplasms, Pancreatic Neoplasms, Rectal Neoplasms, Neoplasms, Cholangiocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Biliary Tract Cancer (BTC) | Patients diagnosed with cholangiocarcinoma or gallbladder carcinoma from 01-01-2017. | |
| Hepatocellular Carcinoma (HCC) | Patients with hepatocellular carcinoma primary diagnosed from 01-01-2017 and treated with systemic therapy. | |
| MSI-High Colorectal Cancer (MSI-H CRC) | Patients with MSI-High colorectal cancer (by PCR or IHQ) and primary pathological diagnosis from 01-01-2017. | |
| Pancreatic Cancer | Patients with exocrine pancreatic cancer diagnosed from 01-01-2019. | |
| Rectal Cancer | Patients diagnosed with rectal cancer from 01-01-2019. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Situation of digestive tumours in Spain
Understanding the situation of digestive tumours in Spain, their epidemiology (risk factors, age, sex), biology and clinical manifestations in order to improve the quality of care, optimise diagnosis and treatment, and identify areas for improvement that can benefit patients.
Measured: For each cohort, an annual data cut-off (12 months) is planned. Epidemiology, therapy and efficacy parameters are analyzed from date of diagnosis to outcome or cut-off date, for registry population (at least baseline visit completed)
Secondary outcomes (3)
Knowledge about situations that can impact digestive tumours
Generate knowledge and scientific evidence on events and situations that may impact on digestive tumours (e.g. COVID-19 coronavirus pandemic).
Measured: An annual data cut-off (12 months) per cohort is planned. Upon specific situations (i.e COVID-19), specific cohorts are open to capture related data
Biological substudies for translational reseach of tumor diagestive diseases
Subjects may consent in translational projects (i.e. biomarkers determination, NGS or DNA analysis, etc), with banked biological samples
Measured: Frequency of translational projects is defined for each indivial substudy, with data captured from firts´subject diagnosis to last subject´s outcome at time of database
Determination of molecular markers
Determination of molecular markers that may be useful healthcare decision-making in patients diagnosed with digestive tumours.
Measured: Frequency of translational projects is defined for each indivial substudy, with data captured from firts´subject diagnosis to last subject´s outcome at time of database
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2024
- Study start23 Dec 2020
- Primary completionDec 2030 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Digestive CancersStudies 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
- 20,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06711211
- Sponsor's protocol ID
- TTD-20-01 RETUD RETUD
- Acronym
- RETUD
- Status last verified
- Nov 2024
- First submitted
- 25 Nov 2024
- Last updated
- 2 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication or a presentation to a scientific congress or meeting
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Descriptive, Multicentre, Observational Epidemiological Study on Digestive Tumours
- ClinicalTrials.gov ID
- NCT06711211
- Acronym / sponsor ID
- RETUD / TTD-20-01 RETUD RETUD
- Conditions
- Digestive Cancers, Bile Duct Cancer, Hepatocellular Cancer (HCC), Colorectal Cancer (CRC), Pancreatic Cancer, Rectal Cancer
- Keywords
- digestive, cancer, tumours, cholangiocarcinoma, hepatocellular, colorectal, pancreas, rectal
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20,000 participants (estimated)
- Lead sponsor
- Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)University, hospital or other
- Study start
- 23 Dec 2020 (actual)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 2 Dec 2024 (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 aim of this observational study is to assess the current state of digestive tumours in Spain. By doing so, it seeks to enhance the quality of care, optimize the diagnosis and treatment of digestive tumours, and identify opportunities for improvement that can benefit patients.
The study will investigate the epidemiological, biological, and clinical characteristics of digestive tumors diagnosed in patients aged 18 and older across healthcare centres in Spain. It also aims to generate knowledge and scientific evidence for events and situations that may impact on patients with digestive tumours (e.g. COVID-19 coronavirus pandemic).
Furthermore, subject to the patient's consent, biological samples may be collected for use in translational research projects and for the identification of molecular markers that may be useful in healthcare decision-making.
Detailed description
Data will be collected ambispectively, recording those patients who were diagnosed with digestive tumours before the start of the study (from 2017) and also those who are diagnosed after the start of the study.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 10 Years
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Biliary Tract Cancer (BTC) | – | –Patients diagnosed with cholangiocarcinoma or gallbladder carcinoma from 01-01-2017. |
| Hepatocellular Carcinoma (HCC) | – | –Patients with hepatocellular carcinoma primary diagnosed from 01-01-2017 and treated with systemic therapy. |
| MSI-High Colorectal Cancer (MSI-H CRC) | – | –Patients with MSI-High colorectal cancer (by PCR or IHQ) and primary pathological diagnosis from 01-01-2017. |
| Pancreatic Cancer | – | –Patients with exocrine pancreatic cancer diagnosed from 01-01-2019. |
| Rectal Cancer | – | –Patients diagnosed with rectal cancer from 01-01-2019. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with digestive tumours in healthcare centres of Spain.
Key inclusion criteria (2 listed)
- Male and female patients ≥18 years old diagnosed with oesophageal cancer, gastric cancer, pancreatic cancer, hepatocarcinoma, gallbladder and bile duct cancer, cancer of the small intestine, appendix and gastrointestinal stroma, colorectal cancer, anal canal cancer or digestive hereditary cancer.
- Written informed consent available.
Key exclusion criteria (1 listed)
- Patient for whom, for whatever reason, it is not possible to know or obtain the information necessary to complete the data collection base.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Situation of digestive tumours in Spain
Time frame: For each cohort, an annual data cut-off (12 months) is planned. Epidemiology, therapy and efficacy parameters are analyzed from date of diagnosis to outcome or cut-off date, for registry population (at least baseline visit completed)
Understanding the situation of digestive tumours in Spain, their epidemiology (risk factors, age, sex), biology and clinical manifestations in order to improve the quality of care, optimise diagnosis and treatment, and identify areas for improvement that can benefit patients.
3 secondary outcomes
Knowledge about situations that can impact digestive tumours
Time frame: An annual data cut-off (12 months) per cohort is planned. Upon specific situations (i.e COVID-19), specific cohorts are open to capture related data
Biological substudies for translational reseach of tumor diagestive diseases
Time frame: Frequency of translational projects is defined for each indivial substudy, with data captured from firts´subject diagnosis to last subject´s outcome at time of database
Determination of molecular markers
Time frame: Frequency of translational projects is defined for each indivial substudy, with data captured from firts´subject diagnosis to last subject´s outcome at time of database
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 2 Dec 2024.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication or a presentation to a scientific congress or meeting
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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.
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 Digestive Cancers and Bile Duct Cancer, run by Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD) at 1 site in Spain.
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 2 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: looking for participants now, as of the sponsor's last update on 2 Dec 2024. 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 Spain. 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?
Contact Esther Mahillo, PhD (+34913788275, ttd@ttdgroup.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Situation of digestive tumours in Spain (time frame: For each cohort, an annual data cut-off (12 months) is planned. Epidemiology, therapy and efficacy parameters are analyzed from date of diagnosis to outcome or cut-off date, for registry population (at least baseline visit completed)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Dec 2024.