Clinical and BIOgical Analyses of RECtal Tumors
Analyzing rectal tumors for better treatment strategies
Plain English Summary
Clinical and BIOgical Analyses of RECtal Tumors is a Not Applicable clinical trial sponsored by Centre Leon Berard studying Rectal Cancer. This study analyzes biological and clinical data from rectal tumors to understand treatment responses. It is for patients who have had surgery for rectal cancer. Participation involves providing existing or new tissue and blood samples. Alternatives include standard treatment without this specific analysis. The trial aims to enroll 300 participants.
Official Summary
Rectal cancer is a common cancer with an incidence of approximately 14,000 new cases per year in France. The survival rate is approximately 50% at 5 years, ranging from 90% for patients with localized rectal cancer to 18% for patients with metastases. Surgery with local or complete exicion is the standard treatment for early stages. The implementation of Total Neoadjuvant Therapy (TNT) for locally advanced stages has led to a significant improvement in the prognosis for rectal cancer. The complete pathological response rate of aproximately 20% after TNT has led to the "Watch and Wait" strategy, which aims to avoid surgery and preserve the rectum, but there is currently no reliable method for identifying responders. Rectal tumors with mismatch repair defiency (MMRd) and/or High microsatellite instability (MSI-H) are considered resistant to neoadjuvant chemotherapy, but those patients can benefit from immunotherapy treatment. Identifying patients who will respond to immunotherapy is crucial for this type of treatment. Pre-existing immune infiltration within the tumor microenvironnement prior to any treatment is an important prognostic factor and could help predict response to immunotherapy, as well as neoadjuvant treatment. Studying the immune microenvironnement and how it changes during different treatments could therefore help identify responders for whom treatment without surgery could be considered in order to avoid the deterioration in quality of life often associated with this procedure in this type of cancer. Finally, analysis of residual tumor cells after chemotherapy and/or chemoradiotherapy could help identify possible mechanisms of resistance to current treatments and develop strategies to counter them.
Who Can Participate
Here is what you need to know about eligibility for this trial. Adults aged 18 and over can join. You must have had surgery for rectal cancer since January 1st, 2019. A confirmed diagnosis of rectal adenocarcinoma from a surgical sample is required. There are no specific exclusion criteria mentioned. This trial is studying Rectal Cancer, so participants generally need a confirmed diagnosis.
What They're Measuring
The primary outcome measures how biological characteristics of rectal tumors relate to their clinical behavior, helping doctors predict treatment success. The specific primary outcome measures are: Establish a correlation between biological data and clinical data of patients with rectal tumors (Until up to 3 years follow-up of the last patient enrolled). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.
Why This Trial Matters
This trial aims to improve rectal cancer treatment by identifying which patients respond best to therapies, potentially avoiding unnecessary surgery and improving quality of life. This research targets Rectal Cancer, where improved treatment options are needed.
Investor Insight
This trial focuses on a common cancer, seeking to refine treatment for advanced stages, which could lead to more targeted therapies and improved survival rates, signaling potential for new treatment d
Is This Trial Right for Me?
Ask your doctor if your past surgical samples can be used for this study. Understand that this study uses existing or collected samples and blood draws as part of your regular care. The study involves analyzing your tumor and blood for biological markers. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: NA
- Model: SINGLE_GROUP
- Masking: NONE
- Enrollment: 300 participants
Interventions
- PROCEDURE: Blood sample collection — Blood sample will be collected during a visit scheduled as part of the standard care for the patient
- PROCEDURE: Tumor Samples — Archival FFPE (Formalin-Fixed Paraffin-Embedded) or Fresh Frozen tumor samples from initial diagnosis, surgery, and metastases in case of relapse will be collected if available.
- PROCEDURE: Healthy tissue sample — A healthy tissue sample from the surgical site (excision margin) of the primary tumor or from an additionnal sample taken during preoperative rectosigmoidoscopy performed as part of the standard care will be collected.
Primary Outcomes
- Establish a correlation between biological data and clinical data of patients with rectal tumors (Until up to 3 years follow-up of the last patient enrolled)
Secondary Outcomes
- Comparison of stroma of tumor samples from : 1) primary tumors operated after preoperative chemotherapy, 2) biopsies performed before chemotherapy and 3) primary tumors operated without preoperative treatment (Until up to 3 years follow-up of the last patient enrolled)
- Comparision of healthy tissue, stroma of primary tumors samples and metastases in patients for whom samples of primary tumor and metastases will be available. (Until up to 3 years follow-up of the last patient enrolled)
Full Eligibility Criteria
Inclusion Criteria: * Male or female aged 18 or over * Patients who have undergone surgery for rectal cancer since January 1st, 2019 * Histological diagnosis of rectal adenocarcinoma confirmed on a surgical sample Exclusion Criteria: * Not applicable
Trial Locations
- Centre Léon Bérard, Lyon, France
Frequently Asked Questions
What is clinical trial NCT07499921?
NCT07499921 is a Not Applicable INTERVENTIONAL study titled "Clinical and BIOgical Analyses of RECtal Tumors." It is currently not yet recruiting and is sponsored by Centre Leon Berard. The trial targets enrollment of 300 participants.
What conditions does NCT07499921 study?
This trial investigates treatments for Rectal Cancer. The primary condition under study is Rectal Cancer.
What treatments are being tested in NCT07499921?
The interventions being studied include: Blood sample collection (PROCEDURE), Tumor Samples (PROCEDURE), Healthy tissue sample (PROCEDURE). Blood sample will be collected during a visit scheduled as part of the standard care for the patient
What does Not Applicable mean for NCT07499921?
This study does not have a defined clinical phase. It may be an observational study, expanded access program, or other non-interventional research.
What is the current status of NCT07499921?
This trial is currently "Not Yet Recruiting." It started on 2026-05-01. The estimated completion date is 2033-05-01.
Who is sponsoring NCT07499921?
NCT07499921 is sponsored by Centre Leon Berard. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT07499921?
The trial aims to enroll 300 participants. The trial has not yet started recruiting.
How is NCT07499921 designed?
This is a interventional study, uses na allocation, follows a single_group design, employs none masking.
What are the primary outcomes being measured in NCT07499921?
The primary outcome measures are: Establish a correlation between biological data and clinical data of patients with rectal tumors (Until up to 3 years follow-up of the last patient enrolled). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT07499921 being conducted?
This trial is being conducted at 1 site, including Lyon (France).
Where can I find official information about NCT07499921?
The official record for NCT07499921 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT07499921. This government database provides the most up-to-date and detailed information about the trial.
What is NCT07499921 testing in simple terms?
This study analyzes biological and clinical data from rectal tumors to understand treatment responses. It is for patients who have had surgery for rectal cancer.
Why is this trial significant?
This trial aims to improve rectal cancer treatment by identifying which patients respond best to therapies, potentially avoiding unnecessary surgery and improving quality of life.
What are the potential risks of participating in NCT07499921?
The main risk is the minimal discomfort associated with blood draws or additional tissue collection. There are no direct treatment risks as this study analyzes existing samples and data. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT07499921?
Ask your doctor if your past surgical samples can be used for this study. Understand that this study uses existing or collected samples and blood draws as part of your regular care. The study involves analyzing your tumor and blood for biological markers. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT07499921 signal from an investment perspective?
This trial focuses on a common cancer, seeking to refine treatment for advanced stages, which could lead to more targeted therapies and improved survival rates, signaling potential for new treatment d This is a Not Applicable trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Participation involves providing existing or new tissue and blood samples. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
Related Conditions
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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.