Prognostic Evaluation and Systematic Re-Assessment of Cholangiocarcinoma Therapy (Re-ACT)
5 septembre 2026 mis à jour par: Hannes Jansson, Karolinska University Hospital
The Re-ACT Study: Prognostic Evaluation and Systematic Re-Assessment of Chol- Angiocarcinoma Therapy
Prospective observational cohort study including patients with a diagnosis of intrahepatic/perihilar cholangiocarcinoma at the central regional multidisciplinary conference, to assess therapy response, patient-reported quality of life, patient-reported symptoms/experiences and biomarkers.
For patients diagnosed with localized unresectable disease, the study will document the multidisciplinary re-assessment of therapy response.
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Type d'étude
Observationnel
Inscription (Estimé)
900
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Hannes Jansson, MD PhD
- Numéro de téléphone: +46 8 123 80 000
- E-mail: hannes.jansson@regionstockholm.se
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
N/A
Méthode d'échantillonnage
Échantillon non probabiliste
Population étudiée
Swedish patients with newly diagnosed intrahepatic- or perihilar cholangiocarcinoma
La description
Inclusion Criteria:
- Clinical diagnosis of intrahepatic- or perihilar cholangiocarcinoma at the regional multidisciplinary team conference
- For inclusion in the re-assessment arm, a diagnosis of localized, unresectable cholangiocarcinoma at the regional multidisciplinary team conference and clinically evaluated as candidate for tumor-directed medical therapy
Exclusion Criteria:
- Age <18 years
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Rate of conversion to resectability, in patients with localized, unresectable cholangiocarcinoma
Délai: At first multidisciplinary re-assessment of therapy response after first-line oncological treatment (typically after 8 cycles, i.e. at an average of approximately 6 months)
|
Change of initial treatment intention
|
At first multidisciplinary re-assessment of therapy response after first-line oncological treatment (typically after 8 cycles, i.e. at an average of approximately 6 months)
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Recurrence-free survival time
Délai: From date of surgery until the date of clinical-radiological recurrence or date of death of any cause, assessed at study completion at an estimated average follow-up of 2 years
|
For patients undergoing curative intent surgery
|
From date of surgery until the date of clinical-radiological recurrence or date of death of any cause, assessed at study completion at an estimated average follow-up of 2 years
|
|
Progression-free survival time
Délai: From therapy starting date until date of first documented progression (recurrence, progressive disease acc. to Response Evaluation Criteria in Solid Tumor) or date of death of any cause, assessed at study completion with est. average follow-up 2 years
|
For patients with tumor-directed therapy. Assessment of progressive disease using Response Evaluation Criteria in Solid Tumor (RECIST criteria): Complete Response - disappearance of all target lesions. Partial Response - ≥30% decrease in sum of diameters. Progressive Disease - ≥20% increase in sum of diameters (minimum 5 mm absolute increase) or appearance of new lesions. Stable Disease: neither partial response nor progressive disease |
From therapy starting date until date of first documented progression (recurrence, progressive disease acc. to Response Evaluation Criteria in Solid Tumor) or date of death of any cause, assessed at study completion with est. average follow-up 2 years
|
|
Overall survival time
Délai: From date of diagnosis until the date of death of any cause, assessed at study completion at an estimated average follow-up of 2 years
|
From date of diagnosis until the date of death of any cause, assessed at study completion at an estimated average follow-up of 2 years
|
|
|
Patient-reported quality of life according to the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
Délai: Sequentially: at inclusion; 1 month after inclusion; before first treatment; 1 month after first treatment; before second treatment; 1 month after second treatment; at 6, 12, 18 and 24 months after inclusion
|
30 item questionnaire with 3 domains: symptoms, functional- and global health status. Items for symptoms and functioning are scored from 1-4 (symptoms - higher score represents higher level of symptomatology; function - higher score represents higher level of functioning). Items for global health status are scored from 1-7 (higher score represents a higher quality of life). Aggregated domain scores are calculated separately, and standardized to a range from 0 to 100, where a high score for symptoms represents a high level of symptomatology; while a high score for function and global health status represents a high level of functioning and a high quality of life. |
Sequentially: at inclusion; 1 month after inclusion; before first treatment; 1 month after first treatment; before second treatment; 1 month after second treatment; at 6, 12, 18 and 24 months after inclusion
|
|
Patient-reported symptoms/experiences according to the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire in Biliary Tract Cancer (EORTC QLQ-BIL21)
Délai: Sequentially: at inclusion; 1 month after inclusion; before first treatment; 1 month after first treatment; before second treatment; 1 month after second treatment; at 6, 12, 18 and 24 months after inclusion
|
The EORTC QLQ-BIL21 questionnaire consists of 21 items: 3 single-question assessments (side effects, difficulties with biliary drainage, concerns regarding weight loss); and 18 questions aggregated into 5 symptom domains (eating, jaundice, tiredness, pain, anxiety).
Each item is scored from 1-4 (higher score represents higher level of symptomatology).
Symptom scores are transformed to a standardized range from 0 to 100, where a high score represents a high level of symptomatology.
|
Sequentially: at inclusion; 1 month after inclusion; before first treatment; 1 month after first treatment; before second treatment; 1 month after second treatment; at 6, 12, 18 and 24 months after inclusion
|
|
Longitudinal assessment of circulating tumor DNA plasma concentration
Délai: At inclusion; 1 month after inclusion; before first treatment; 1 month after first treatment, and then every 2 months; before second treatment; 1 month after second treatment and then every 2 months up to 24 months after inclusion
|
tumor molecules / mL of plasma
|
At inclusion; 1 month after inclusion; before first treatment; 1 month after first treatment, and then every 2 months; before second treatment; 1 month after second treatment and then every 2 months up to 24 months after inclusion
|
|
Longitudinal assessment of plasma cytokine profile
Délai: At inclusion; 1 month after inclusion; before first treatment; 1 month after first treatment, and then every 2 months; before second treatment; 1 month after second treatment and then every 2 months up to 24 months after inclusion
|
Plasma cytokine concentrations (pg/mL)
|
At inclusion; 1 month after inclusion; before first treatment; 1 month after first treatment, and then every 2 months; before second treatment; 1 month after second treatment and then every 2 months up to 24 months after inclusion
|
|
Recurrence-free survival rate
Délai: At 6, 12, 18 and 24 months from the date of surgery
|
The proportion of patients with curative-intent surgery surviving without a clinical-radiological diagnosis of recurrence
|
At 6, 12, 18 and 24 months from the date of surgery
|
|
Progression-free survival rate
Délai: At 6, 12, 18 and 24 months from the starting date of therapy
|
The proportion of patients with tumor-directed therapy surviving without documented progression (recurrence, progressive disease according to Response Evaluation Criteria in Solid Tumor [RECIST criteria]). RECIST criteria: Complete Response - disappearance of all target lesions. Partial Response - ≥30% decrease in sum of diameters. Progressive Disease - ≥20% increase in sum of diameters (minimum 5 mm absolute increase) or appearance of new lesions. Stable Disease: neither partial response nor progressive disease |
At 6, 12, 18 and 24 months from the starting date of therapy
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
1 septembre 2026
Achèvement primaire (Estimé)
1 septembre 2029
Achèvement de l'étude (Estimé)
1 décembre 2031
Dates d'inscription aux études
Première soumission
2 septembre 2026
Première soumission répondant aux critères de contrôle qualité
5 septembre 2026
Première publication (Réel)
11 septembre 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
11 septembre 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
5 septembre 2026
Dernière vérification
1 septembre 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2026-00080-01/2026-04284-02
Plan pour les données individuelles des participants (IPD)
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INDÉCIS
Description du régime IPD
Public access may be restricted by applicable laws and regulations that prohibit the release of data that could potentially allow a personal identification.
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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