Clinical trial · Interventional
A Clinicobiological Database in Metastatic Digestive Cancers
Development of a Prospective Clinicobiological Database in Metastatic Digestive Cancers
NCT03978078CI-TRIAL-00085846BCB-CBIO-DIGrecruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Digestive System Neoplasm | Digestive System Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biological collection | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Biological collection
- description
- For 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
- interventionNames
- Other: Biological collection
Primary outcomes (2)
- measure
- Number of clinical risk factors for metastatic digestive cancer
- timeFrame
- Until the study completion : 54 months
- measure
- Number of biological risk factors for metastatic digestive cancer
- timeFrame
- Until the study completion : 54 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Male or female ≥ 18 years old 2. Histological documentation of adenocarcinoma of the colon or rectum, small intestine, pancreas, stomach, bile duct, oesophagus 3. Patient who will receive a first or second line metastatic chemotherapy and/or targeted therapy 4. Informed consent form (ICF) signed Exclusion Criteria: 1. Male or female \< 18 years old 2. Non-adenocarcinoma histological type 3. Patient already undergoing specific treatment (chemotherapy and/or targeted therapy) in 1st or 2nd metastatic line 4. Pregnant and/or breastfeeding woman 5. Patient not affiliated to a social security system 6. Patient whose regular follow-up is impossible for psychological, family, social or geographical reasons 7. Patient who is included in a Phase I-II therapeutic trial modifying usual management and involving additional and specific blood samples
References
Publications (4)
- BACKGROUNDBray 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 22752881
- BACKGROUNDKarapetis 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 18946061
- BACKGROUNDDouillard 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 24024839
- BACKGROUNDBang 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 20728210