RecruitingACTRN12622001047785

Australian Comprehensive Molecular Evaluation of Advanced Biliary Cancer Trial (ACME ABC)

Feasibility and role for comprehensive molecular evaluation for Advanced Biliary Cancer (ABC) in Australia.

Sponsor

Australasian Gastro-Intestinal Cancer Trials Group (AGITG)

Enrollment

50 participants

Start Date

Feb 23, 2023

Study Type

Interventional

Conditions

Biliary cancer / Cholangiocarcinoma

Summary

Biliary Cancer (BC) or Cholangiocarcinoma remains a rare but important cause of cancer related mortality worldwide. Although surgical resection can be curative, most patients present with advanced disease not suitable for surgery. Current chemotherapy has improved median survival to 1-2 years for these patients. The aim of this study is to examine the feasibility and benefit or role for integrating comprehensive molecular profiling (CMP) of advanced biliary cancer (ABC) using tissue collected during routine diagnostic tests or procedures. Who is it for? You may be eligible to join this study if you are aged 18 years or older, have suspected advanced biliary tract cancer, and are either scheduled for an endoscopy procedure or have pre-existing "biobanked" (stored) endoscopic biopsy tissue. Study Details: All participants will have been reviewed in a multi-disciplinary meeting and deemed suitable for inclusion in the trial. Those enrolled will be asked to provide a sample of their pre-existing or upcoming cancer biopsy tissue. The tissue will be collected at the time of the routine endoscopic procedure, or from the existing tissue sample stored at the hospital. Then, 6 months after providing the tissue sample, participants will be called by a member of the study team for telephone interview asking about disease progress and diagnosis. Additionally, information related to advanced biliary cancer diagnosis will be directly collected from medical records for the 12 month period after providing the tissue sample. It is hoped this research will show that comprehensive molecular profiling (CMP) on samples obtained /biopsies from routine diagnostic tests is able to perform comprehensive molecular profiling of advanced biliary tract cancer, and improve the detail on the profile and accuracy of cancer diagnosis.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

Biliary tract cancer (also called cholangiocarcinoma or bile duct cancer) is a rare but serious cancer that is usually diagnosed at a late, inoperable stage. Chemotherapy can extend survival, but outcomes remain poor. In other cancers, detailed molecular profiling — analysing the specific genetic and molecular characteristics of a tumour — has led to more targeted, personalised treatment approaches. This study tests whether comprehensive molecular profiling (CMP) of biliary tract cancer is feasible using biopsy samples collected during standard diagnostic endoscopy procedures. Participants either have an upcoming endoscopy procedure for diagnosis or stenting, or have previously consented to have their biopsy tissue stored. The tumour tissue is analysed for its full molecular profile. Six months and twelve months after providing the sample, participants are followed up to assess disease progression and whether the molecular results informed treatment decisions. You may be eligible if you are 18 or older, have suspected advanced, recurrent, or metastatic biliary tract cancer, are considered suitable for chemotherapy, and are either scheduled for an endoscopy or have stored biopsy tissue available. People with operable disease, liver metastases from another primary cancer, or serious medical conditions preventing chemotherapy are not eligible.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Patients with suspected diagnosis of ABC who have a good performance status are candidates for entry into this trial. If participants are later found to have a benign condition, they will be excluded

Patients with suspected diagnosis of ABC who have a good performance status are candidates for entry into this trial. If participants are later found to have a benign condition, they will be excluded from the assessment of primary and relevant secondary outcomes. Potential participants will have been identified at and reviewed at multi-disciplinary team meeting (MDT) and are not suitable for surgical resection as the tumour is locally advanced, metastatic or recurrent. Participants will provide informed consent for additional biopsies to be taken at the initial or subsequent endoscopic interventions (endoscopic ultrasound with fine needle biopsy or direct cholangioscopy with biopsies) for the routine diagnosis and management of cholangiocarcinoma. No additional procedures will be organised for research biopsies but if a patient requires a replacement stent or repeat procedure for their diagnosis, then that would be the opportunity for the additional biopsies for the genomic profiling to be obtained. These biopsies from EUS or direct cholangioscopy will be obtained by a highly skilled interventional endoscopist (typically a gastroenterologist or a hepatopancreaticobiliary surgeon). The extra biopsies typically may add 2-5 minutes to the procedure and blood samples will be obtained by the anaesthetist via the existing cannula or additional venepuncture whilst the patient has the endoscopic procedure. DNA and RNA will be extracted from these additional biopsies using a standardised protocol (from Qiagen) and then quantified. If the quality of the genomic material is sufficient, then it will progress to have whole genome sequencing (WGS) completed through the Victorian Comprehensive Cancer Centre run by Professor Sean Grimmond. Peripheral blood taken at the time of the endoscopic procedure will be stored for future circulating tumour DNA analysis and possible comprehensive molecular profiling. After molecular profiling of biopsies has been completed and the results will be reviewed in the forum of a MTB. If a patient is potentially suitable or eligible for potential participation in therapeutic trials, then they may be referred to MoST (ACTRN12616000908437)

Locations(3)

Monash Medical Centre - Clayton campus - Clayton

SA,VIC, Australia

St Vincent's Hospital (Melbourne) Ltd - Fitzroy

SA,VIC, Australia

The Royal Adelaide Hospital - Adelaide

SA,VIC, Australia

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ACTRN12622001047785