ClinicalTrials.gg
RecruitingNCT03976960BCBCOLONUpdated Feb 12, 2025

Clinical and Biological Database in Colon Cancer and Colic Tumors

An interventional study of Biological collection in Cancer Colon, sponsored by Institut du Cancer de Montpellier - Val d'Aurelle. Recruiting at 2 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-12.

Sponsored by Institut du Cancer de Montpellier - Val d'Aurelle · Not applicable, Interventional, and Other

From the registry’s dates

  • Primary completion was expected by Dec 2025, 11 months ago, but the record still lists the study as recruiting.
  • Registered 8 months after the study started (first participant enrolled Sep 2018, registered Jun 2019).
  • Started Sep 2018; still recruiting 8 years 1 month later.
Phase
Not applicable
Study type
Interventional
Enrollment
600
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study 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 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.

02

Conditions studied

  • Cancer Colon

Keywords

  • cancer
  • colon
  • tumor
  • colic
03

In context

Colonic Neoplasms

2,457 studies on the registry are indexed under Colonic Neoplasms; 458 are open to participants now.

This study's planned enrollment of 600 is above the median of 75 across 1,711 interventional studies indexed under Colonic Neoplasms.

Browse Colonic Neoplasms studies →

Lead sponsor

Institut du Cancer de Montpellier - Val d'Aurelle is the lead sponsor of 142 studies on the registry; 47 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Patient undergoing colon cancer surgery (stage I, II, III and IV)
  2. Patient operated for liver or lung or peritoneal carcinomatosis originating from colon cancer
  3. Patient operated for pre-neoplastic lesion (adenomatous polyp /villous adenoma polyp),
  4. Patient with familial polyposis eligible for colectomy
  5. Age > 18 years
  6. Signed

Exclusion criteria

Exclusion Criteria:

  1. Patient not affiliated to Social Protection system
  2. Patient unable to understand or comply with study instructions or requirements for psychological, family, social or geographical reasons
  3. Patient under guardianship
  4. Minor patient
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
600 participants (estimated)

Study arms

  • Experimental
    Biological collection

    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

    Other: Biological collection

Interventions

  • OtherBiological collection

    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.

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What researchers measure

Primary outcomes

  1. Number of clinical risk factors for colorectal cancer

    Time frame: Until the study completion : 6 years

  2. Number of biological risk factors for colorectal cancer

    Time frame: Until the study completion : 6 years

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Study locations

2 of 2 sites recruiting
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References and documents

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Sep 2018 (actual). Primary completion is estimated for Dec 2025, 87 months after the start.

Of 382 non-industry interventional studies with no phase under Colonic Neoplasms, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 55. This study's planned 87 months is above that.

Counting every sponsor, half of 404 studies reached it within 30 months; a quarter within 16 and three quarters within 51.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 5, 2019
First posted
Jun 6, 2019
StartActual
Sep 19, 2018
Primary completionEst.
Dec 2025
CompletionEst.
Dec 2030
Last update
Feb 12, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 12, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03976960
Responsible party
Sponsor
First posted
Jun 6, 2019
Start date
Sep 19, 2018
Primary completion
Dec 2025 (estimated)
Completion
Dec 2030 (estimated)
Last update
Feb 12, 2025

Study contacts

Aurore MOUSSION
Contact
DRCI-icm105@icm.unicancer.fr
4 67 61 31 02 ext. + 33
ERIC ASSENAT, M.D
study chair · Institut régional du cancer de Montpellier

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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