Rectal NeoplasmsTECARENCT06442215
Selection of Surgical Technique in Rectal Cancer
An observational study of Rectal Neoplasms, run by Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta at 1 site in Spain.
Trial summary
Currently, there is no prediction scale available to identify patients with rectal neoplasms as technically complex in the middle and lower thirds; that is, those who are at high risk of affected circumferential margins and low quality of the mesorectum. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Neoplasms
- What is being tested?
- Data collection
- How many people
- 333 participants
- Where
- 1 siteSpain
- Study dates
- 3 Apr 2024to 3 Apr 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 rectal neoplasia undergoing elective surgery during a period of time from 2017 to 2021
Who may be able to join
- Scheduled surgery for anterior resection of the rectum meeting oncological criteria with mesorectal excision.
- Age ≥ 18 years.
- Histology of adenocarcinoma with or without neoadjuvant chemotherapy or chemoradiotherapy.
- Initial stage T1-T4a. Any N. Any M.
- Intention for R0 resection.
Who cannot join
- Colorectal tumor with histology different from adenocarcinoma.
- Synchronous colon tumor.
- Benign pathology or adenoma.
- Tis.
- T4b or oncological multivisceral resections.
- History of neoplastic colorectal surgery or local excision or TAMIS.
- Perforated or obstructive rectal neoplasm.
Trial locations and contacts
1 site in 1 country.
Lidia Cornejo, MSC contact
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitari Dr. Josep Trueta de Girona
Girona, 17300
Nuria Ortega, MD, 972420200 ext. 2825, nortega.girona.ics@gencat.cat
About this study
Official title: Selection of Surgical Technique in Rectal Cancer Through the Development of a Predictive Model for Optimal Oncological Outcomes
Currently, there is no prediction scale available to identify patients with rectal neoplasms as technically complex in the middle and lower thirds; that is, those who are at high risk of affected circumferential margins and low quality of the mesorectum. The application of a predictive model that allows preoperative identification of the group of patients in whom optimal results in mesorectal quality and circumferential margin are less likely to be obtained through laparoscopic or minimally invasive surgery would enable the selection of patients who will require and justify all efforts and healthcare resources to improve surgical outcomes.
Therefore, the investigators aim to create a predictive model to identify these patients, allowing the discrimination of which patients will benefit from different techniques, or even which ones would be opportune to initially consider an open approach.
- Conditions
- Rectal Neoplasms
- Being tested
- Data collection
- Keywords
- Rectal cancer, Surgery, Minimal invasive surgery, Oncological outcomes
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collectionOther
Collection of preoperative demographic, clinical, and radiological variables from patients who meet the inclusion criteria in order to identify possible risk factors for suboptimal surgical treatment
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing elective surgery for rectal neoplasm | Patients diagnosed with rectal neoplasia undergoing elective surgery between 2017 and 2021 at medical centers within the national territory. Receives: Other: Data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Suboptimal oncological outcomes
Surgical resection with affected margins (proximal-distal and/or circumferential < 1mm) and/or incomplete or nearly complete mesorectal resection
Measured: 15 postoperative days
Secondary outcomes (2)
Surgical and Postoperative complications
Conversion to open surgery and anastomotic dehiscence rates
Measured: 30 postoperative days
Overall and disease free survival
Recurrence of the tumoral disease at the pelvic level and distant recurrence is defined as s the recurrence of the disease in other distant organs.
Measured: 3-years surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2024
- Study start3 Apr 2024
- Primary completion3 Apr 2025 (estimated)
- Study completion3 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal NeoplasmsStudies 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
- Retrospective
- Enrolment
- 333 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06442215
- Sponsor's protocol ID
- 2024.017
- Acronym
- TECARE
- Status last verified
- Jun 2024
- First submitted
- 29 May 2024
- Last updated
- 5 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Selection of Surgical Technique in Rectal Cancer Through the Development of a Predictive Model for Optimal Oncological Outcomes
- ClinicalTrials.gov ID
- NCT06442215
- Acronym / sponsor ID
- TECARE / 2024.017
- Conditions
- Rectal Neoplasms
- Keywords
- Rectal cancer, Surgery, Minimal invasive surgery, Oncological outcomes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 333 participants (estimated)
- Lead sponsor
- Institut d'Investigació Biomèdica de Girona Dr. Josep TruetaUniversity, hospital or other
- Study start
- 3 Apr 2024 (actual)
- Primary completion
- 3 Apr 2025 (estimated)
- Study completion
- 3 Apr 2026 (estimated)
- First posted
- 4 Jun 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.
Currently, there is no prediction scale available to identify patients with rectal neoplasms as technically complex in the middle and lower thirds; that is, those who are at high risk of affected circumferential margins and low quality of the mesorectum. The application of a predictive model that allows preoperative identification of the group of patients in whom optimal results in mesorectal quality and circumferential margin are less likely to be obtained through laparoscopic or minimally invasive surgery would enable the selection of patients who will require and justify all efforts and healthcare resources to improve surgical outcomes.
Therefore, the investigators aim to create a predictive model to identify these patients, allowing the discrimination of which patients will benefit from different techniques, or even which ones would be opportune to initially consider an open approach.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing elective surgery for rectal neoplasm | – | Other: Data collectionPatients diagnosed with rectal neoplasia undergoing elective surgery between 2017 and 2021 at medical centers within the national territory. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with rectal neoplasia undergoing elective surgery during a period of time from 2017 to 2021
Key inclusion criteria (5 listed)
- Scheduled surgery for anterior resection of the rectum meeting oncological criteria with mesorectal excision.
- Age ≥ 18 years.
- Histology of adenocarcinoma with or without neoadjuvant chemotherapy or chemoradiotherapy.
- Initial stage T1-T4a. Any N. Any M.
- Intention for R0 resection.
Key exclusion criteria (7 listed)
- Colorectal tumor with histology different from adenocarcinoma.
- Synchronous colon tumor.
- Benign pathology or adenoma.
- Tis.
- T4b or oncological multivisceral resections.
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 |
|---|---|---|
| Data collectionCollection of preoperative demographic, clinical, and radiological variables from patients who meet the inclusion criteria in order to identify possible risk factors for suboptimal surgical treatment | Other | Patients undergoing elective surgery for rectal neoplasm |
Primary outcome
Suboptimal oncological outcomes
Time frame: 15 postoperative days
Surgical resection with affected margins (proximal-distal and/or circumferential < 1mm) and/or incomplete or nearly complete mesorectal resection
2 secondary outcomes
Surgical and Postoperative complications
Time frame: 30 postoperative days
Overall and disease free survival
Time frame: 3-years surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2024.
- 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.
Lidia Cornejo, MSC contact
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 Rectal Neoplasms, run by Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta 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 5 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 5 Jun 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nuria Ortega, MD (972 940 200 ext. 2825, nortega.girona.ics@gencat.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Suboptimal oncological outcomes (time frame: 15 postoperative days). 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 5 Jun 2024.