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A Clinicobiological Database in Metastatic Digestive Cancers (BCB-CBIO-DIG)

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ClinicalTrials.gov Identifier: NCT03978078
Recruitment Status : Recruiting
First Posted : June 6, 2019
Last Update Posted : July 9, 2019
Sponsor:
Information provided by (Responsible Party):
Institut du Cancer de Montpellier - Val d'Aurelle

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.

Condition or disease Intervention/treatment Phase
Digestive System Neoplasm Other: Biological collection Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Development of a Prospective Clinicobiological Database in Metastatic Digestive Cancers
Actual Study Start Date : September 12, 2016
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : April 2026

Arm Intervention/treatment
Experimental: Biological collection

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

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




Primary Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03978078


Contacts
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Contact: Jean-Pierre Bleuse, MD 4 67 61 31 02 ext +33 jean-pierre.bleuse@icm.unicancer.fr

Locations
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France
Institut régional du cancer de Montpellier Recruiting
Montpellier, Hérault, France, 34298
Contact: Thibault Mazard, MD    4.67.61.31.36 ext +33    thibault.mazard@icm.unicancer.fr   
Sponsors and Collaborators
Institut du Cancer de Montpellier - Val d'Aurelle
Investigators
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Study Chair: Thibault Mazard, MD Institut régional du cancer de Montpellier

Publications:
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Responsible Party: Institut du Cancer de Montpellier - Val d'Aurelle
ClinicalTrials.gov Identifier: NCT03978078     History of Changes
Other Study ID Numbers: ICM-URC 2016/08
First Posted: June 6, 2019    Key Record Dates
Last Update Posted: July 9, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Institut du Cancer de Montpellier - Val d'Aurelle:
colorectal
pancreas
stomach
oesophagus
bile duct
small intestine
cancer

Additional relevant MeSH terms:
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Digestive System Neoplasms
Gastrointestinal Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases