ClinicalTrials.gg
RecruitingNCT03449264BCBInstitutUpdated Feb 12, 2025

Development of Clinical and Biological Database

An interventional study of biological collection in Digestive Cancer, Gynecologic Cancer and Breast Cancer, sponsored by Institut du Cancer de Montpellier - Val d'Aurelle. Recruiting at 1 site 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

  • Started Jul 2017; still recruiting 9 years 3 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
4,000
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 63 studies in Gastrointestinal Neoplasms with a site in France — 27 open to participants now, 32 under way, 3 of them phase 3. Gastrointestinal Neoplasms · France.

Planned enrollment
2nd of 51
4,000 · median 200
Started
2017
with 3 others
No phase
23 of 63
13 open now
Primary completion
2027-11
later than 15 of 31 live
Registered
15th of 63
by date
Lead sponsor
3 of 63
Institut du Cancer de Montpellier - Val d'Aurelle

Among the 63 studies in Gastrointestinal Neoplasms with a site in France, this one is the 2nd largest by planned enrollment of the 51 interventional ones that give a count, is one of 4 that started in 2017, is one of 23 with no phase, reaches primary completion later than 15 of the 31 other live ones, and was the 15th registered.

Gastrointestinal Neoplasms

695 studies on the registry are indexed under Gastrointestinal Neoplasms; 209 are open to participants now.

Browse Gastrointestinal Neoplasms studies →

Open to participants now

27 of the 63 studies in Gastrointestinal Neoplasms with a site in France are open now. Recruiting first, the newest first:

21 more — sign in →

All 27 open studies →

A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →

Who these studies take

Of the 160 Gastrointestinal Neoplasms studies recruiting now, 122 (76%) set no upper age limit and 18 (11%) stop at 75 or younger; 8 take children under 18; 9 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 63 studies in Gastrointestinal Neoplasms with a site in France, or all of them as a file.
02

Study summary

The BCB is a tool:

  • for research in analytical and public health epidemiology, biological research and for the development of data useful for clinical research and therapeutic trials;
  • to help scientists understand and explain phenomena ranging from the interaction of molecules to the whole metabolism of the organism in normal and pathological situations;
  • to identify potential strategies for prevention, diagnosis, management and analysis of cancer subtypes.

The creation of a broad clinical and biological prospective base dedicated to different types of cancer is essential for the development of such projects.

Read the detailed description

Implementation of a translational research project is part of the Cancer Plan 2014-2019 and its axis 5 "Advancing clinical and translational research in oncology", and more precisely Action 5.1.

The national health strategy launched by the Minister of Health and the Minister of Research will allow a better integration between research, innovation, medicine and care for the benefit of patients and society.

Moreover, knowledge of mechanisms involved in the phenomena of tumor invasion, metastatic dissemination, resistance to treatment and companion testing is crucial for the emergence of new biomarkers and therapeutic innovation.

However, the study of the earliest phases of tumorigenesis as well as of the advanced stages of the disease are currently limited by the low availability of blood and tissue samples combined with quality and reliable clinical data.

To meet these demands, the research must then integrate databases creation open to researchers and the ongoing evaluation of the impact of projects on the health of cancer patients.

Integrated research associated with quality biological research is the guarantee of medical progress.

The multidisciplinary structure around collections of biological resources will enable the various actors to harmonize not only the collection but also the sharing of their data with a view to making them available for medico-scientific projects at a regional and national dimension. The Clinical Biological Database (BCB) should be used to identify and characterize new molecular markers for better diagnosis and / or treatment. It should also permit to optimize the collection of all this information, their integration and their transversal exploitation by different research disciplines (epidemiological, fundamental, translational, clinical).

The BCB is a tool:

  • for research in analytical and public health epidemiology, biological research and for the development of data useful for clinical research and therapeutic trials;
  • to help scientists understand and explain phenomena ranging from the interaction of molecules to the whole metabolism of the organism in normal and pathological situations;
  • to identify potential strategies for prevention, diagnosis, management and analysis of cancer subtypes.

The creation of a broad clinical and biological prospective base dedicated to different types of cancer is essential for the development of such projects

03

Conditions studied

  • Digestive Cancer
  • Gynecologic Cancer
  • Breast Cancer
  • Sarcoma
04

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

  • Age> at 18 years old,
  • Patient with invasive or in situ tumor pathology (proven or suspected) any stage confounded,
  • Patient in ICM at diagnosis

    • a digestive cancer (esophagus, stomach, pancreas, colon, rectum, anal canal) or
    • gynecological cancer (ovary, endometrium, cervix) or
    • breast cancer or
    • sarcoma.
  • Naïve patient of any treatment for the present cancer,
  • Patient requiring treatment involving at least one (or more) tumor surgery (s)
  • Patient who has accepted supplementary blood samples,
  • Patient having given his informed, written and express consent.

Exclusion criteria

Exclusion Criteria:

  • Patient not affiliated to a social protection scheme,
  • Patient whose regular follow-up is a priori impossible for psychological, familial, social or geographical reasons,
  • Pregnant and / or nursing women,
  • Subject under tutelage, curatorship or safeguard of justice,
  • Patient in an emergency situation.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
4,000 participants (estimated)

Study arms

  • Experimental
    Biological collection

    samples of different natures: * Tissue samples (tumor tissue and healthy tissue) frozen and secured in paraffin collected during surgery. * Blood samples taken at different times. During the blood samples taken for diagnosis and / or treatment, additional samples for research purposes will be carried out. In parallel to this biological collection, standardized clinical data will be entered into a database

    Biological: biological collection

Interventions

  • Biologicalbiological collection

    * Tissue samples (tumor tissue and healthy tissue) frozen and secured in paraffin collected during surgery. * Blood samples taken at different times. During the blood samples taken for diagnosis and / or treatment, additional samples for research purposes will be carried out.

06

What researchers measure

Primary outcomes

  1. Proportion of patients who consent to participate in the study

    the proportion of patients who consent to participate in the study among the screened patients

    Time frame: through study completion, an average of 1 year

Other outcomes

  1. Quality of life assessment at baseline for all participants in the study

    Questionnaire assessment to measure the quality of life at baseline

    Time frame: through study completion, an average of 1 year

07

Study locations

1 of 1 sites recruiting
  • Institut regional du Cancer - Val d Aurelle
    Montpellier, 34298, France
    Recruiting
    • BLEUSE Jean-pierre, MHD · Contact
    • AZRIA David, PhD · Principal investigator
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

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 Jul 2017 (actual). Primary completion is estimated for Nov 2027, 124 months after the start.

Of 153 non-industry interventional studies with no phase under Gastrointestinal Neoplasms, half reached primary completion within 39 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 71. This study's planned 124 months is above that.

Counting every sponsor, half of 163 studies reached it within 35 months; a quarter within 17 and three quarters within 71.

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

Registered
Aug 29, 2017
First posted
Feb 28, 2018
StartActual
Jul 27, 2017
Primary completionEst.
Nov 2027
CompletionEst.
Nov 2037
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 ↗
10

Registry details

Key details

Study ID
NCT03449264
Responsible party
Sponsor
First posted
Feb 28, 2018
Start date
Jul 27, 2017
Primary completion
Nov 2027 (estimated)
Completion
Nov 2037 (estimated)
Last update
Feb 12, 2025

Study contacts

david azria
Contact
david.azria@icm.unicancer.fr
+33467613102
jean pierre Bleuse
study chair · Institut régional du Cancer de Montpellier

Oversight

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

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