A Clinicobiological Database in Metastatic Digestive Cancers
BCB-CBIO-DIG
Development of a Prospective Clinicobiological Database in Metastatic Digestive Cancers
1 other identifier
interventional
200
1 country
1
Brief Summary
Creation of a collection of blood samples that will be collected before and then under treatment in patients with digestive adenocarcinoma during the 1st and 2nd metastatic line and which, depending on scientific progress, can be used for research projects aimed at developing tailored patient management strategies.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2016
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 12, 2016
CompletedFirst Submitted
Initial submission to the registry
June 5, 2019
CompletedFirst Posted
Study publicly available on registry
June 6, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2031
February 12, 2025
February 1, 2025
10 years
June 5, 2019
February 11, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of clinical risk factors for metastatic digestive cancer
Until the study completion : 54 months
Number of biological risk factors for metastatic digestive cancer
Until the study completion : 54 months
Study Arms (1)
Biological collection
EXPERIMENTALFor all the patients include in the study : \- Blood samples collected at different times : Before treatment, during treatment (approximately every other month) through the end of treatment In parallel to this biological collection, standardized clinical data will be entered into a database
Interventions
\- Blood samples collected at different times : Before treatment, during treatment (approximately every other month) through the end of treatment
Eligibility Criteria
You may qualify if:
- Male or female ≥ 18 years old
- Histological documentation of adenocarcinoma of the colon or rectum, small intestine, pancreas, stomach, bile duct, oesophagus
- Patient who will receive a first or second line metastatic chemotherapy and/or targeted therapy
- Informed consent form (ICF) signed
You may not qualify if:
- Male or female \< 18 years old
- Non-adenocarcinoma histological type
- Patient already undergoing specific treatment (chemotherapy and/or targeted therapy) in 1st or 2nd metastatic line
- Pregnant and/or breastfeeding woman
- Patient not affiliated to a social security system
- Patient whose regular follow-up is impossible for psychological, family, social or geographical reasons
- Patient who is included in a Phase I-II therapeutic trial modifying usual management and involving additional and specific blood samples
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Institut régional du cancer de Montpellier
Montpellier, Hérault, 34298, France
Related Publications (4)
Bray F, Ren JS, Masuyer E, Ferlay J. Global estimates of cancer prevalence for 27 sites in the adult population in 2008. Int J Cancer. 2013 Mar 1;132(5):1133-45. doi: 10.1002/ijc.27711. Epub 2012 Jul 26.
PMID: 22752881BACKGROUNDKarapetis CS, Khambata-Ford S, Jonker DJ, O'Callaghan CJ, Tu D, Tebbutt NC, Simes RJ, Chalchal H, Shapiro JD, Robitaille S, Price TJ, Shepherd L, Au HJ, Langer C, Moore MJ, Zalcberg JR. K-ras mutations and benefit from cetuximab in advanced colorectal cancer. N Engl J Med. 2008 Oct 23;359(17):1757-65. doi: 10.1056/NEJMoa0804385.
PMID: 18946061BACKGROUNDDouillard JY, Oliner KS, Siena S, Tabernero J, Burkes R, Barugel M, Humblet Y, Bodoky G, Cunningham D, Jassem J, Rivera F, Kocakova I, Ruff P, Blasinska-Morawiec M, Smakal M, Canon JL, Rother M, Williams R, Rong A, Wiezorek J, Sidhu R, Patterson SD. Panitumumab-FOLFOX4 treatment and RAS mutations in colorectal cancer. N Engl J Med. 2013 Sep 12;369(11):1023-34. doi: 10.1056/NEJMoa1305275.
PMID: 24024839BACKGROUNDBang YJ, Van Cutsem E, Feyereislova A, Chung HC, Shen L, Sawaki A, Lordick F, Ohtsu A, Omuro Y, Satoh T, Aprile G, Kulikov E, Hill J, Lehle M, Ruschoff J, Kang YK; ToGA Trial Investigators. Trastuzumab in combination with chemotherapy versus chemotherapy alone for treatment of HER2-positive advanced gastric or gastro-oesophageal junction cancer (ToGA): a phase 3, open-label, randomised controlled trial. Lancet. 2010 Aug 28;376(9742):687-97. doi: 10.1016/S0140-6736(10)61121-X. Epub 2010 Aug 19.
PMID: 20728210BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Thibault Mazard, MD
Institut régional du cancer de Montpellier
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 5, 2019
First Posted
June 6, 2019
Study Start
September 12, 2016
Primary Completion (Estimated)
September 1, 2026
Study Completion (Estimated)
September 1, 2031
Last Updated
February 12, 2025
Record last verified: 2025-02
Data Sharing
- IPD Sharing
- Will not share