Biliary Tract CancerNCT03419247
Molecular Profiling of Advanced Biliary Tract Cancers
A study testing Fresh tumor tissue biopsy, Blood draw and Archival tumor tissue collection in people with Biliary Tract Cancer, run by University Health Network, Toronto.
Trial summary
This is a study where fresh tumor tissue and blood samples will be collected from patients with advanced biliary tract cancer who will be undergoing 1st line therapy with gemcitabine or fluorouracil (5-FU) regimens to see how useful it is to look for changes and characteristics in genes (molecules that contain… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Biliary Tract Cancer
- What is being tested?
- Fresh tumor tissue biopsy, Blood draw and Archival tumor tissue collection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2020to 2 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have a histological or radiological diagnosis of inoperable or metastatic biliary tract cancer (BTC).
- Patient must have a tumor lesion that is amenable to a core needle biopsy as judged by a staff radiologist.
- Patients must have a measurable lesion by RECIST 1.1 in addition to the lesion that is going to be biopsied.
- Patients must be fit enough to safely undergo a tumor biopsy as judged by the investigator.
- Eastern Cooperative Group (ECOG) performance status ≤ 1 (Karnofsky ≥60%).
- Life expectancy of greater than 90 days, as judged by the investigator.
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- Within 14 days of the proposed biopsy date, patients must have normal organ and marrow function.
- Patients must undergo systemic treatment with gemcitabine or 5-FU based regimens as first line standard systemic palliative treatment with or without other investigational agents within a clinical trial.
- Ability to understand and willing to sign a written informed consent document.
Who cannot join
- Patients with one or more contraindications to tumor biopsy.
- Patients who have had prior systemic treatment (chemotherapy or any other anti-cancer agent) in the advanced setting.
- Patients who are currently on anti-cancer treatment including chemotherapy.
- Patients with known brain metastases are excluded from participation in this clinical study.
- Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures
About this study
Official title: Comprehensive Molecular Profiling of Advanced Biliary Tract Cancers (BTC) for Better Treatment Selection: A Prospective Study (COMPASS B)
This is a study where fresh tumor tissue and blood samples will be collected from patients with advanced biliary tract cancer who will be undergoing 1st line therapy with gemcitabine or fluorouracil (5-FU) regimens to see how useful it is to look for changes and characteristics in genes (molecules that contain instructions for the development and functioning of the cells) and the genes within the tumour to find characteristics that may be useful in choosing treatments for patients in the future.
Read the detailed description
Changes (mutations) in genes have been shown to be an important characteristic in cancers. Looking at differences in genes in patients with unresectable or metastatic biliary tract cancer and comparing this information with response to their initial chemotherapy treatment may help to learn which treatments may be better for certain patients after initial treatment.
- Conditions
- Biliary Tract Cancer
- Being tested
- Fresh tumor tissue biopsy, Blood draw, Archival tumor tissue collection
- Medical subject headings
- Biliary Tract Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fresh tumor tissue biopsyProcedure or surgery
A type of surgical procedure that will use a thin needle to remove a sample of tumor tissue.
Blood drawProcedure or surgery
Blood will be taken by a needle from a vein.
Archival tumor tissue collectionProcedure or surgery
A sample of tumor tissue that was taken by biopsy or surgery before agreeing to take part in this study will be collected.
| Study group | Role | What they receive |
|---|---|---|
| Tumor tissue and blood sample collection | Experimental | Not described Receives: Procedure: Fresh tumor tissue biopsy; Procedure: Blood draw; Procedure: Archival tumor tissue collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with gene testing data available at 8 weeks from baseline tumor biopsy.
Measured: 8 Weeks
Secondary outcomes (6)
Disease control rate
Measured: 4 years
Progression-free survival rate
Measured: 4 years
Overall survival rate
Measured: 4 years
Genomic predictors of response to chemotherapy identified
Measured: 4 years
Germline mutations of hereditary risk factors
Measured: 4 years
Potential predictive biomarkers of response to treatment such as BRCA, PALB2 and ATM mutations.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2018
- Study start1 Jan 2020 (estimated)
- Primary completion2 Jan 2022 (estimated)
- Study completion2 Jan 2023 (estimated)
Why it stopped: Study was not activated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biliary Tract CancerStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jennifer J Knox, M.D., Principal investigator, Princess Margaret Cancer Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03419247
- Sponsor's protocol ID
- COMPASS-B
- Status last verified
- Mar 2021
- First submitted
- 7 Dec 2017
- Last updated
- 1 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Molecular Profiling of Advanced Biliary Tract Cancers (BTC) for Better Treatment Selection: A Prospective Study (COMPASS B)
- ClinicalTrials.gov ID
- NCT03419247
- Acronym / sponsor ID
- COMPASS-B
- Conditions
- Biliary Tract Cancer
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study was not activated
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 1 Jan 2020 (estimated)
- Primary completion
- 2 Jan 2022 (estimated)
- Study completion
- 2 Jan 2023 (estimated)
- First posted
- 1 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a study where fresh tumor tissue and blood samples will be collected from patients with advanced biliary tract cancer who will be undergoing 1st line therapy with gemcitabine or fluorouracil (5-FU) regimens to see how useful it is to look for changes and characteristics in genes (molecules that contain instructions for the development and functioning of the cells) and the genes within the tumour to find characteristics that may be useful in choosing treatments for patients in the future.
Detailed description
Changes (mutations) in genes have been shown to be an important characteristic in cancers. Looking at differences in genes in patients with unresectable or metastatic biliary tract cancer and comparing this information with response to their initial chemotherapy treatment may help to learn which treatments may be better for certain patients after initial treatment.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tumor tissue and blood sample collection | Experimental | Procedure: Fresh tumor tissue biopsy, Procedure: Blood draw, Procedure: Archival tumor tissue collection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients must have a histological or radiological diagnosis of inoperable or metastatic biliary tract cancer (BTC).
- Patient must have a tumor lesion that is amenable to a core needle biopsy as judged by a staff radiologist.
- Patients must have a measurable lesion by RECIST 1.1 in addition to the lesion that is going to be biopsied.
- Patients must be fit enough to safely undergo a tumor biopsy as judged by the investigator.
- Eastern Cooperative Group (ECOG) performance status ≤ 1 (Karnofsky ≥60%).
Key exclusion criteria (6 listed)
- Patients with one or more contraindications to tumor biopsy.
- Patients who have had prior systemic treatment (chemotherapy or any other anti-cancer agent) in the advanced setting.
- Patients who are currently on anti-cancer treatment including chemotherapy.
- Patients with known brain metastases are excluded from participation in this clinical study.
- Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fresh tumor tissue biopsyA type of surgical procedure that will use a thin needle to remove a sample of tumor tissue. | Procedure or surgery | Tumor tissue and blood sample collection |
| Blood drawBlood will be taken by a needle from a vein. | Procedure or surgery | Tumor tissue and blood sample collection |
| Archival tumor tissue collectionA sample of tumor tissue that was taken by biopsy or surgery before agreeing to take part in this study will be collected. | Procedure or surgery | Tumor tissue and blood sample collection |
Primary outcome
Number of participants with gene testing data available at 8 weeks from baseline tumor biopsy.
Time frame: 8 Weeks
6 secondary outcomes
Disease control rate
Time frame: 4 years
Progression-free survival rate
Time frame: 4 years
Overall survival rate
Time frame: 4 years
Genomic predictors of response to chemotherapy identified
Time frame: 4 years
Germline mutations of hereditary risk factors
Time frame: 4 years
Potential predictive biomarkers of response to treatment such as BRCA, PALB2 and ATM mutations.
Time frame: 4 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer J Knox, M.D. principal investigator
Princess Margaret Cancer Centre
Questions about this trial
What is this clinical trial studying?
A study testing Fresh tumor tissue biopsy, Blood draw and Archival tumor tissue collection in people with Biliary Tract Cancer, run by University Health Network, Toronto.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 1 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with gene testing data available at 8 weeks from baseline tumor biopsy. (time frame: 8 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2021.