Prognostic Evaluation and Systematic Re-Assessment of Cholangiocarcinoma Therapy

Browse trials for

• Cholangiocarcinoma 824Registry's first term
• Klatskin Tumor 82Primary · reclassified

Klatskin Tumor Reclassified

82 studies on the registry are indexed under Klatskin Tumor; 27 are open to participants now.

This study's planned enrollment of 900 is above the median of 200 across 23 observational studies indexed under Klatskin Tumor.

Lead sponsor

Karolinska University Hospital is the lead sponsor of 279 studies on the registry; 55 are open to participants now.

Study population

Primary outcomes

1. Rate of conversion to resectability, in patients with localized, unresectable cholangiocarcinoma

   Change of initial treatment intention

   Time frame: 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)

Secondary outcomes

1. Recurrence-free survival time

   For patients undergoing curative intent surgery

   Time frame: 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

2. Progression-free survival time

   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

   Time frame: 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

3. Overall survival time

   Time frame: 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

4. Patient-reported quality of life according to the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)

   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.

   Time frame: 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

5. 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)

   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.

   Time frame: 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

6. Longitudinal assessment of circulating tumor DNA plasma concentration

   tumor molecules / mL of plasma

   Time frame: 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

7. Longitudinal assessment of plasma cytokine profile

   Plasma cytokine concentrations (pg/mL)

   Time frame: 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

8. Recurrence-free survival rate

   The proportion of patients with curative-intent surgery surviving without a clinical-radiological diagnosis of recurrence

   Time frame: At 6, 12, 18 and 24 months from the date of surgery

9. Progression-free survival rate

   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

   Time frame: At 6, 12, 18 and 24 months from the starting date of therapy

Individual participant data

Plan to share: Undecided — Public access may be restricted by applicable laws and regulations that prohibit the release of data that could potentially allow a personal identification.