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

Biliary Tract Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04935853
• Other study ID #: ACABi PRONOBIL GB-115
• Status: Recruiting
• Start date: May 23, 2022
• Est. completion date: June 1, 2040

Study information

• Verified date: January 2024
• Source: GERCOR - Multidisciplinary Oncology Cooperative Group
• Contact: Cindy Neuzillet, Dr
• Phone: +33 (0)1 47 11 15 15
• Email: cindy.neuzillet[@]curie.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1350
• Est. completion date: June 1, 2040
• Est. primary completion date: June 1, 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Biliary Tract Cancer
• Biliary Tract Neoplasms

Locations

Country	Name	City	State
France	CHU Hôpital Sud Amiens	Amiens
France	CHU Angers	Angers
France	CHU Besançon	Besançon
France	Hôpital Avicenne	Bobigny
France	CHU - Henri Mondor	Créteil
France	CHU Dijon	Dijon
France	CHU Grenoble	Grenoble
France	CHU Lille	Lille
France	Centre Léon Bérard	Lyon
France	Hôpital Croix Rousse	Lyon
France	Hôpital Edouard Herriot	Lyon
France	Hôpital Privé Jean Mermoz	Lyon
France	Institut Paoli Calmette	Marseille
France	CHU Saint Eloi Montpellier	Montpellier
France	CHU Nantes	Nantes
France	Centre Antoine Lacassagne	Nice
France	CHR Orléans	Orléans
France	Groupe Hospitalier Pitié Salpêtrière	Paris
France	Hôpital Ambroise Paré	Paris
France	Hôpital Cochin	Paris
France	Hôpital Saint Antoine	Paris
France	Hôpital Saint Louis	Paris
France	Institut Mutualiste Montsouris	Paris
France	Hôpital Haut Lévêque	Pessac
France	CHU Poitiers	Potiers
France	Hôpital Robert Debré -CHU Reims	Reims
France	Centre Eugène Marquis	Rennes
France	CHU Rouen Charles Nicolle	Rouen
France	Institut Curie	Saint-Cloud
France	CHU Saint Etienne	Saint-Étienne
France	CHU Rangueil	Toulouse
France	CHU Tours	Tours
France	CHRU Nancy Site Brabois	Vandœuvre-lès-Nancy
France	Institut Gustave Roussy	Villejuif

Sponsors (1)

Lead Sponsor	Collaborator
GERCOR - Multidisciplinary Oncology Cooperative Group

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of patients with advanced bile duct cancer (BDC) experiencing overall survival (OS) less than 6 months	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.	Up to 10 years from the date of initial cancer diagnosis (or until death if it occurs before 10 years)
Secondary	Rate of patients with localized bile duct cancer (BDC) experiencing overall survival (OS) less than 6 months	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.	Up to 10 years from the date of initial cancer diagnosis (or until death if it occurs before 10 years)
Secondary	Response rate	Assessment of treatments effects on the response rate (RECIST v 1.1, Choi).	Up to 10 years from the date of initial cancer diagnosis (or until death if it occurs before 10 years)
Secondary	Effect of treatments on secondary resection rate R0 of the primary tumor	Assessment of treatments on secondary resection rate R0 of the primary tumor	From day of surgical intervention until 30 days
Secondary	Effects of treatments on disease-free survival (DFS)	Assessment of treatments effects on disease-free survival (DFS) in patients who underwent surgery.	Up to 10 years; The months between surgery and the first documented recurrence, second cancer, or death from any cause
Secondary	Effects of treatments on progression-free survival (PFS)	Assessment of treatments effects on progression-free survival (PFS) in non-operated patients	Up to 10 years; The months between the start of treatment and the first progression or death, whatever be the cause
Secondary	Toxicities (Adverse events) experienced by patients	Evaluation of toxicity assessed by CTCAE v 5.0	Up to 10 years from the date of initial cancer diagnosis (or until death if it occurs before 10 years)
Secondary	The complications and postoperative mortality rates in patients who underwent surgery	Assessment of the complications rate (Clavien classification) and of postoperative mortality in patients who underwent surgery	From day of surgical intervention until 30 days; up to 10 years