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Prognostic and Predictive Markers of Response to Treatment in Patients With Bile Duct Cancer: ACABi PRONOBIL Study

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ClinicalTrials.gov Identifier: NCT04935853
Recruitment Status : Not yet recruiting
First Posted : June 23, 2021
Last Update Posted : June 23, 2021
Sponsor:
Information provided by (Responsible Party):
GERCOR - Multidisciplinary Oncology Cooperative Group

Brief Summary:
The objective of this study is to identify prognosis and predictive markers of response to treatments (surgery, chemotherapy, targeted therapy,loco-regional treatments ) in patients with bile duct cancer. The effectiveness and tolerance of these treatments in current practice will also be evaluated.

Condition or disease
Biliary Tract Cancer

Detailed Description:

Bile duct cancers are a heterogeneous group of rare tumors with a poor prognosis. Surgery is the only curative modality for localized forms. Chemotherapy is the standard treatment in advanced forms. Identification of prognostic and predictive markers to better stratify patients and to guide therapeutic decisions is a major issue. It is retro-prospective (diagnosis between 2003 and 2021) and prospective (diagnosis between 2021 and 2030) multi-center, cohort study. Follow-up for 10 years from initial cancer diagnosis will be done.

Follow-up is retrospective only for patients operated on or diagnosed in the past for more than 10 years, and retro-prospective for operated patients or diagnosed in the past for less than 10 years.

The data collected for each patient are available during the life cycle of this clinical trial to fulfil an educational requirement (e.g. a doctoral thesis) upon request and authorization from the study committee and the study sponsor (GERCOR).

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Study Type : Observational
Estimated Enrollment : 1350 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: Marqueurs Pronostiques et prédictifs de réponse Aux Traitements Chez Les Patients Atteints de Cancer Des Voies Biliaires : Cohorte Multicentrique ACABi PRONOBIL
Estimated Study Start Date : June 30, 2021
Estimated Primary Completion Date : June 1, 2030
Estimated Study Completion Date : June 1, 2040

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Rate of patients with advanced bile duct cancer (BDC) experiencing overall survival (OS) less than 6 months [ Time Frame: Up to 10 years from the date of initial cancer diagnosis (or until death if it occurs before 10 years) ]

    Identification of clinical and tumor predictive factors of overall survival (OS) (prognostic markers) in patients with advanced bile duct cancer (BDC).

    OS defined as a period between the start of treatment and death, whatever the cause.



Secondary Outcome Measures :
  1. Rate of patients with localized bile duct cancer (BDC) experiencing overall survival (OS) less than 6 months [ Time Frame: Up to 10 years from the date of initial cancer diagnosis (or until death if it occurs before 10 years) ]

    Identification of clinical and tumor predictive factors of overall survival (OS) (prognostic markers) in patients with bile localized BDC (operated).

    OS defined as a period between the start of treatment and death, whatever the cause.


  2. Response rate [ Time Frame: Up to 10 years from the date of initial cancer diagnosis (or until death if it occurs before 10 years) ]
    Assessment of treatments effects on the response rate (RECIST v 1.1, Choi).

  3. Effect of treatments on secondary resection rate R0 of the primary tumor [ Time Frame: From day of surgical intervention until 30 days ]
    Assessment of treatments on secondary resection rate R0 of the primary tumor

  4. Effects of treatments on disease-free survival (DFS) [ Time Frame: Up to 10 years; The months between surgery and the first documented recurrence, second cancer, or death from any cause ]
    Assessment of treatments effects on disease-free survival (DFS) in patients who underwent surgery.

  5. Effects of treatments on progression-free survival (PFS) [ Time Frame: Up to 10 years; The months between the start of treatment and the first progression or death, whatever be the cause ]
    Assessment of treatments effects on progression-free survival (PFS) in non-operated patients

  6. Toxicities (Adverse events) experienced by patients [ Time Frame: Up to 10 years from the date of initial cancer diagnosis (or until death if it occurs before 10 years) ]
    Evaluation of toxicity assessed by CTCAE v 5.0

  7. The complications and postoperative mortality rates in patients who underwent surgery [ Time Frame: From day of surgical intervention until 30 days; up to 10 years ]
    Assessment of the complications rate (Clavien classification) and of postoperative mortality in patients who underwent surgery



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Retro-prospective (diagnosis between 2003 and 2020) and prospective (diagnosis between 2021 and 2030) cohorts of patients with Bile Duct Cancer
Criteria

Inclusion Criteria:

  • All locations of primitives (intrahepatic CCA, extrahepatic CCA, adenocarcinoma of the gallbladder; ampullomas excluded)
  • Age > 18 years
  • Diagnosed between 2003 and 2030 (minimum follow-up 2 years)
  • Written written non-opposition +/- signed informed consent for genetic studies (N.B.:

exemption requested for a deceased patient) N.B. Authorized inclusion in a therapeutic research protocol

Exclusion Criteria:

  • Patient under guardianship, curatorship or legal protection
  • Pregnant or breastfeeding women
  • Any medical, psychological or social situation, which could prevent the compliance with the protocol according to the investigator's assessment
  • Refusal to participate in the study

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): NCT04935853


Contacts
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Contact: Cindy Neuzillet, Dr +33 (0)1 47 11 15 15 cindy.neuzillet@curie.fr
Contact: Marie-Line Garcia, Dr +33 (0)1 40 29 85 00 marie-line.garcia-larnicol@gercor.com.fr

Sponsors and Collaborators
GERCOR - Multidisciplinary Oncology Cooperative Group
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Responsible Party: GERCOR - Multidisciplinary Oncology Cooperative Group
ClinicalTrials.gov Identifier: NCT04935853    
Other Study ID Numbers: ACABi PRONOBIL GB-115
First Posted: June 23, 2021    Key Record Dates
Last Update Posted: June 23, 2021
Last Verified: May 2021

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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 GERCOR - Multidisciplinary Oncology Cooperative Group:
predictive
prognostic
biliary track cancer
Additional relevant MeSH terms:
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Biliary Tract Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Biliary Tract Diseases
Digestive System Diseases