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NCT Number: NCT04935853

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

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.

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Key information

Conditions

Biliary Tract Cancer Biliary Tract Diseases Biliary Tract Neoplasms Digestive System Diseases Digestive System Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Hôpital Sud Amiens, Amiens, France

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About this study

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).

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Study contacts

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

Cindy Neuzillet, Dr

CONTACT

[email protected]

+33 (0)1 47 11 15 15

Marie-Line Garcia, Dr

CONTACT

[email protected]

+33 (0)1 40 29 85 00

Sponsors and collaborators

Lead sponsor

GERCOR - Multidisciplinary Oncology Cooperative Group

Other

Registry information

Official study title

Marqueurs Pronostiques et prédictifs de réponse Aux Traitements Chez Les Patients Atteints de Cancer Des Voies Biliaires : Cohorte Multicentrique ACABi PRONOBIL

Important dates

Study start
2022
Primary completion
2030
Study completion
2040
First posted
Jun 23, 2021
Registry last updated
Jul 23, 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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