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A Clinicobiological Database in Metastatic Digestive Cancers

Development of a Prospective Clinicobiological Database in Metastatic Digestive Cancers

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03978078
Acronym
BCB-CBIO-DIG
Enrollment
200
Registered
2019-06-06
Start date
2016-09-12
Completion date
2031-09-30
Last updated
2025-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Digestive System Neoplasm

Keywords

colorectal, pancreas, stomach, oesophagus, bile duct, small intestine, cancer

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.

Detailed description

Digestive cancers account for 30% of all cancers. The most common of these colorectal cancer (CRC) is the third most common cause of cancer in the world. In the metastatic phase, patients with digestive cancers generally benefit from medical treatment based on cytotoxic chemotherapy, which can be combined with targeted therapy in certain locations. Their use is based on demonstrating a significant improvement in the overall survival of patients. However, the therapeutic choice and follow-up of these treatments as a the first line treatment and beyond remain difficult given a cruel lack of biomarkers capable of predicting the response to these different molecules upstream but also usable during treatment to evaluate their efficacy or identify the development of secondary resistance mechanisms. Indeed, the only biomarkers currently validated and used before the initiation of anti-cancer treatment to stratify patients are: * the search for mutations in Kirsten rat sarcoma viral oncogene homolog (KRAS) and neuroblastoma rat sarcoma viral oncogene (NRAS) oncogenes as predictive factors for non-response to anti-Epidermal Growth Factor receptor (EGFR) in colorectal adenocarcinomas. * the search for overexpression of the human epidermal growth factor (HER2) receptor to introduce trastuzumab treatment in esophageal adenocarcinomas. In addition, they are conventionally determined from tumor tissue, which requires an invasive biopsy or surgical sampling that is difficult to repeat over time. In this context, it seems essential to us to identify new parameters allowing a better personalization of anti-cancer treatments, by favouring blood biomarkers that have the advantage of being evaluated in a minimally invasive manner and therefore be repeated to be able to judge tumor dynamics. To this end, we propose the creation of a collection of samples that will be collected before and then under treatment in patients with digestive adenocarcinoma in 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.

Interventions

OTHERBiological collection

\- Blood samples collected at different times : Before treatment, during treatment (approximately every other month) through the end of treatment

Sponsors

Institut du Cancer de Montpellier - Val d'Aurelle
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Number of clinical risk factors for metastatic digestive cancerUntil the study completion : 54 months
Number of biological risk factors for metastatic digestive cancerUntil the study completion : 54 months

Countries

France

Contacts

Primary ContactAurore MOUSSION
jean-pierre.bleuse@icm.unicancer.fr4 67 61 31 02

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026