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

Официальное название

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

Обзор

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.

Подробное описание

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).

Первичные конечные точки

• Rate of patients with advanced bile duct cancer (BDC) experiencing overall survival (OS) less than 6 months [Срок оценки: Up to 10 years from the date of initial cancer diagnosis (or until death if it occurs before 10 years)]

Вторичные конечные точки (7)

• Rate of patients with localized bile duct cancer (BDC) experiencing overall survival (OS) less than 6 months [Срок оценки: Up to 10 years from the date of initial cancer diagnosis (or until death if it occurs before 10 years)]
• Response rate [Срок оценки: Up to 10 years from the date of initial cancer diagnosis (or until death if it occurs before 10 years)]
• Effect of treatments on secondary resection rate R0 of the primary tumor [Срок оценки: From day of surgical intervention until 30 days]
• Effects of treatments on disease-free survival (DFS) [Срок оценки: Up to 10 years; The months between surgery and the first documented recurrence, second cancer, or death from any cause]
• Effects of treatments on progression-free survival (PFS) [Срок оценки: Up to 10 years; The months between the start of treatment and the first progression or death, whatever be the cause]
• Toxicities (Adverse events) experienced by patients [Срок оценки: Up to 10 years from the date of initial cancer diagnosis (or until death if it occurs before 10 years)]
• The complications and postoperative mortality rates in patients who underwent surgery [Срок оценки: From day of surgical intervention until 30 days; up to 10 years]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Франция · 32 центра

• CHU Hôpital Sud Amiens — Amiens
• CHU Angers — Angers
• CHU Besançon — Besançon
• Hôpital Avicenne — Bobigny
• CHU - Henri Mondor — Créteil
• CHU Dijon — Dijon
• CHU Grenoble — Grenoble
• CHU Lille — Lille
• … и ещё 24 центра

Публикации

• Noe C, Henriques J, Chanez B, Vernerey D, Lecomte T, Durand A, Assenat E, Edeline J, Heurgue A, Tougeron D, Manfredi S, Hautefeuille V, Neuzillet C, Roth G, Lagasse JP, Tournigand C, Delaye M, Hollebecque A, Turpin A, Parent P. Adjuvant capecitabine in resected biliary tract cancer: a real-world data from the BILCAP-Real study (ACABi multicentre cohort). JHEP Rep. 2026 Jul 28:101968. doi: 10.1016/ PMID 42520930
• Adamus N, Edeline J, Henriques J, Fares N, Lecomte T, Turpin A, Vernerey D, Vincens M, Chanez B, Tougeron D, Tournigand C, Assenat E, Delaye M, Manfredi S, Bouche O, Williet N, Vienot A, Blaise L, Mas L, Neuzillet C, Boileve A, Roth GS. First-line chemotherapy with selective internal radiation therapy for intrahepatic cholangiocarcinoma: The French ACABi GERCOR PRONOBIL cohort. JHEP Rep. 2024 Nov PMID 39897613

Идентификаторы

NCT: NCT04935853 · ACABi PRONOBIL GB-115

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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