Prognostic Evaluation and Systematic Re-Assessment of Cholangiocarcinoma Therapy (Re-ACT)
5. september 2026 opdateret af: 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.
Studieoversigt
Status
Ikke rekrutterer endnu
Undersøgelsestype
Observationel
Tilmelding (Anslået)
900
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Hannes Jansson, MD PhD
- Telefonnummer: +46 8 123 80 000
- E-mail: hannes.jansson@regionstockholm.se
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
N/A
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Swedish patients with newly diagnosed intrahepatic- or perihilar cholangiocarcinoma
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Rate of conversion to resectability, in patients with localized, unresectable cholangiocarcinoma
Tidsramme: 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)
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Recurrence-free survival time
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
1. september 2026
Primær færdiggørelse (Anslået)
1. september 2029
Studieafslutning (Anslået)
1. december 2031
Datoer for studieregistrering
Først indsendt
2. september 2026
Først indsendt, der opfyldte QC-kriterier
5. september 2026
Først opslået (Faktiske)
11. september 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
11. september 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
5. september 2026
Sidst verificeret
1. september 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2026-00080-01/2026-04284-02
Plan for individuelle deltagerdata (IPD)
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IPD-planbeskrivelse
Public access may be restricted by applicable laws and regulations that prohibit the release of data that could potentially allow a personal identification.
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