Cancer ColonBCBCOLONNCT03976960
Clinical and Biological Database in Colon Cancer and Colic Tumors
A study testing Biological collection in people with Cancer Colon, run by Institut du Cancer de Montpellier - Val d'Aurelle at 2 sites in France.
Trial summary
Developement of a clinical and biological database in colon cancer and colic tumors in order to better understand tumor invasion and metastatic scattering processes. The investigators hope that a better understanding of tumoral invasion process will lead to the discovery of new biomarkers and new drugs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer Colon
- What is being tested?
- Biological collection
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 2 sitesFrance
- Study dates
- 19 Sep 2018to Dec 2030
- Phase
- Interventional
- 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
Who may be able to join
- Patient undergoing colon cancer surgery (stage I, II, III and IV)
- Patient operated for liver or lung or peritoneal carcinomatosis metastases originating from colon cancer
- Patient operated for pre-neoplastic lesion (adenomatous polyp /villous adenoma polyp),
- Patient with familial polyposis eligible for colectomy
- Age > 18 years
- Signed informed consent
Who cannot join
- Patient not affiliated to Social Protection system
- Patient unable to understand or comply with study instructions or requirements for psychological, family, social or geographical reasons
- Patient under guardianship
- Minor patient
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Recruiting
CHRU de Montpellier
Montpellier, Hérault, 34298
Eric Assénat, MD, 467330137 ext. +33, e-assenat@chu-montpellier.fr
- Recruiting
Institut Régional du cancer de Montpellier
Montpellier, 34298
ERIC ASSENAT, MD
About this study
Official title: Prospective, Multicenter, Clinical and Biological Database Set-up in Colon Cancer and Colic Tumors
Developement of a clinical and biological database in colon cancer and colic tumors in order to better understand tumor invasion and metastatic scattering processes. The investigators hope that a better understanding of tumoral invasion process will lead to the discovery of new biomarkers and new drugs.
Read the detailed description
As the second leading cause of cancer-related death in France, colorectal cancer is a major public health problem. Each year, 37 000 cases are newly diagnosed in France and 17 000 patients die of the disease.
Colorectal cancer is due to molecular and genetic damages involved in all tumorigenesis steps, transition from healthy tissue to adenoma and finally to invasive carcinoma stage. The investigators hope that a to better understand tumor invasion and metastatic scattering processes will allow therapeutic innovation and the emergence of new biomarkers.
However, the study of early tumorigenesis phases as well as advanced stages of the disease is currently limited due to a lack of tissue samples.
In this context, the Montpellier Cancer Institute (ICM) decided to initiate a biological collection dedicated to the tissular and blood samples of patients with colorectal cancer.
- Conditions
- Cancer Colon
- Being tested
- Biological collection
- Keywords
- cancer, colon, tumor, colic
- Medical subject headings
- Colonic Neoplasms, Neoplasms, Colic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biological collectionOther
The biological collection will also include samples of blood samples collected before or after surgery but also samples frozen and/or paraffin-embedded tissue sections.
| Study group | Role | What they receive |
|---|---|---|
| Biological collection | Experimental | For all the patients include in the study :
samples of blood samples collected before or after surgery but also samples in paraffin-embedded tissue sections.
In parallel to this biological collection, standardized clinical data will be entered into a database Receives: Other: Biological collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of clinical risk factors for colorectal cancer
Measured: Until the study completion : 6 years
Number of biological risk factors for colorectal cancer
Measured: Until the study completion : 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2019
- Study start19 Sep 2018
- Primary completionDec 2025 (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 Cancer ColonStudies of the same condition, open and under way.
- More trials run by Institut du Cancer de Montpellier - Val d'AurelleThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- ERIC ASSENAT, M.D, Study chair, Institut régional du cancer de Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03976960
- Sponsor's protocol ID
- BCB2014/01
- Acronym
- BCBCOLON
- Status last verified
- Feb 2025
- First submitted
- 5 Jun 2019
- Last updated
- 12 Feb 2025
- Results posted
- 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 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multicenter, Clinical and Biological Database Set-up in Colon Cancer and Colic Tumors
- ClinicalTrials.gov ID
- NCT03976960
- Acronym / sponsor ID
- BCBCOLON / BCB2014/01
- Conditions
- Cancer Colon
- Keywords
- cancer, colon, tumor, colic
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Institut du Cancer de Montpellier - Val d'AurelleUniversity, hospital or other
- Study start
- 19 Sep 2018 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 6 Jun 2019 (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.
Developement of a clinical and biological database in colon cancer and colic tumors in order to better understand tumor invasion and metastatic scattering processes. The investigators hope that a better understanding of tumoral invasion process will lead to the discovery of new biomarkers and new drugs.
Detailed description
As the second leading cause of cancer-related death in France, colorectal cancer is a major public health problem. Each year, 37 000 cases are newly diagnosed in France and 17 000 patients die of the disease.
Colorectal cancer is due to molecular and genetic damages involved in all tumorigenesis steps, transition from healthy tissue to adenoma and finally to invasive carcinoma stage. The investigators hope that a to better understand tumor invasion and metastatic scattering processes will allow therapeutic innovation and the emergence of new biomarkers.
However, the study of early tumorigenesis phases as well as advanced stages of the disease is currently limited due to a lack of tissue samples.
In this context, the Montpellier Cancer Institute (ICM) decided to initiate a biological collection dedicated to the tissular and blood samples of patients with colorectal cancer.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Biological collection | Experimental | Other: Biological collectionFor all the patients include in the study : samples of blood samples collected before or after surgery but also samples in paraffin-embedded tissue sections. In parallel to this biological collection, standardized clinical data will be entered into a database |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient undergoing colon cancer surgery (stage I, II, III and IV)
- Patient operated for liver or lung or peritoneal carcinomatosis metastases originating from colon cancer
- Patient operated for pre-neoplastic lesion (adenomatous polyp /villous adenoma polyp),
- Patient with familial polyposis eligible for colectomy
- Age > 18 years
Key exclusion criteria (4 listed)
- Patient not affiliated to Social Protection system
- Patient unable to understand or comply with study instructions or requirements for psychological, family, social or geographical reasons
- Patient under guardianship
- Minor patient
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 |
|---|---|---|
| Biological collectionThe biological collection will also include samples of blood samples collected before or after surgery but also samples frozen and/or paraffin-embedded tissue sections. | Other | Biological collection |
Primary outcome
Number of clinical risk factors for colorectal cancer
Time frame: Until the study completion : 6 years
Number of biological risk factors for colorectal cancer
Time frame: Until the study completion : 6 years
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 12 Feb 2025.
- National estimate of cancer incidence and mortality in France between 1980 and 2012.Link provided by the sponsor.
- 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.
ERIC ASSENAT, M.D study chair
Institut régional du cancer de Montpellier
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biological collection in people with Cancer Colon, run by Institut du Cancer de Montpellier - Val d'Aurelle at 2 sites in France.
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 6 inclusion and 4 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 12 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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 Aurore MOUSSION (4 67 61 31 02 ext. + 33, DRCI-icm105@icm.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of clinical risk factors for colorectal cancer (time frame: Until the study completion : 6 years). The study lists 2 primary outcomes in all. 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 12 Feb 2025.