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NCT Number: NCT03978078

A Clinicobiological Database in Metastatic Digestive Cancers

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut régional du cancer de Montpellier

Montpellier, Hérault, 34298, France

Location status: Recruiting

Location contact

Thibault Mazard, MD

CONTACT

[email protected]

4.67.61.31.36 ext. +33

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Biological collection

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

Primary outcomes

  1. Number of clinical risk factors for metastatic digestive cancer

    Time frame: Until the study completion : 54 months

  2. Number of biological risk factors for metastatic digestive cancer

    Time frame: Until the study completion : 54 months

Study contacts

Contact information is provided by the study sponsor or research team.

Aurore MOUSSION

CONTACT

[email protected]

4 67 61 31 02 ext. +33

Sponsors and collaborators

Lead sponsor

Institut du Cancer de Montpellier - Val d'Aurelle

Other

Registry information

Official study title

Development of a Prospective Clinicobiological Database in Metastatic Digestive Cancers

Acronym: BCB-CBIO-DIG

Important dates

Study start
2016
Primary completion
2026
Study completion
2031
First posted
Jun 6, 2019
Registry last updated
Feb 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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