Intrahepatic CholangiocarcinomaNCT02762721
Analysis of Oncogenes in Intrahepatic Cholangiocarcinoma or Mixed Hepatocellular-Cholangiocarcinoma in Tumor Tissue Samples
An observational study of Intrahepatic Cholangiocarcinoma and Mixed Hepatocellular Cholangiocarcinoma, run by ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA) at 6 sites in 2 countries.
Trial summary
The primary objective of this study is to estimate the frequency of FGFR2 fusions in archived intrahepatic cholangiocarcinoma (iCCA) or mixed hepatocellular-cholangiocarcinoma (HCC-CCA) tumor samples Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intrahepatic Cholangiocarcinoma, Mixed Hepatocellular Cholangiocarcinoma, Cholangiocarcinoma
- How many people
- 131 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 6 Jun 2016to 6 Apr 2017
- Phase
- Observational
- 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
Study population: One hundred and fifty archived tumor tissue samples from patients with iCCA or mixed HCC-CCA will be collected from five to fifteen research sites in the United States and Italy and/or from commercially available sources. No new surgical procedures will be required and no treatment will be provided as part of this study.
Who may be able to join
- If required by law or local regulations (i.e., the sample is from an identifiable subject), signed written informed consent should be granted prior to use of the sample in the study
- ≥ 18 years of age
- Histologically or cytologically confirmed iCCA or mixed HCC-CCA, who are/were eligible for systemic therapy (samples collected prior to initiation of the systemic therapy may be submitted for testing)
- Have one or more formalin fixed and paraffin embedded blocks available. If blocks are not evaluable, 7-10 unstained, non-baked slides with 5-micron thick sections with at least 20% tumor tissue should be available. (Potential participants who are scheduled to undergo surgical treatment may agree to provide surplus of tissues not required for diagnosis and have to provide informed consent prior to the surgery.)
Who cannot join
- Not applicable: Patients must meet all of the inclusion criteria.
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
Italy4 sites
Study site
Benevento, 82100
Study site
Milan, 20133
Study site
Pisa, 56126
Study site
Rozzano, MI, 20089
United States2 sites
Study site
Atlanta, Georgia, 30322
Study site
Seattle, Washington, 98109
About this study
Official title: Molecular Analysis of Oncogenes in Tumor Samples From Adult Patients With Intrahepatic Cholangiocarcinoma or Mixed Hepatocellular-Cholangiocarcinoma
The primary objective of this study is to estimate the frequency of FGFR2 fusions in archived intrahepatic cholangiocarcinoma (iCCA) or mixed hepatocellular-cholangiocarcinoma (HCC-CCA) tumor samples
Read the detailed description
This is a non-interventional, observational study of archived human tissue samples; no surgical procedures will be required and no treatment will be provided as part of this study. Approximately 150 archived tissue samples obtained from patients with iCCA or mixed HCC-CCA will be analyzed for somatic alteration status and will include cholangiocarcinoma-specific FGFR2 fusion isoforms.
- Conditions
- Intrahepatic Cholangiocarcinoma, Mixed Hepatocellular Cholangiocarcinoma, Cholangiocarcinoma
- Keywords
- FGFR2 fusion, iCCA, mixed HCC-CCA, Intrahepatic Cholangiocarcinoma, Mixed Hepatocellular Cholangiocarcinoma, Cholangiocarcinoma, ArQule
- Medical subject headings
- Cholangiocarcinoma, Liver Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimate the frequency of FGFR2 fusions in archived iCCA or mixed HCC-CCA tumor tissue samples
Archived tumor samples will be collected and analyzed using a Next Generation Sequencing panel.
Measured: Archived tumor samples will be collected through study completion, up to 18 months
Secondary outcomes (2)
Determine the frequency of potential actionable mutations or genetic alterations in iCCA or mixed HCC-CCA
Archived tumor samples will be collected and analyzed using a Next Generation Sequencing panel.
Measured: Archived tumor samples will be collected through study completion, up to 18 months
Formulate genetic screening recommendations for newly diagnosed patients with iCCA or mixed HCC-CCA
Archived tumor samples will be collected and analyzed using a Next Generation Sequencing panel.
Measured: Archived tumor samples will be collected through study completion, up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2016 (estimated)
- Study start6 Jun 2016
- Primary completion6 Apr 2017
- Study completion6 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intrahepatic CholangiocarcinomaStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02762721
- Sponsor's protocol ID
- ARQ NIS-001
- Status last verified
- Jun 2017
- First submitted
- 2 May 2016
- Last updated
- 8 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Analysis of Oncogenes in Tumor Samples From Adult Patients With Intrahepatic Cholangiocarcinoma or Mixed Hepatocellular-Cholangiocarcinoma
- ClinicalTrials.gov ID
- NCT02762721
- Acronym / sponsor ID
- ARQ NIS-001
- Conditions
- Intrahepatic Cholangiocarcinoma, Mixed Hepatocellular Cholangiocarcinoma, Cholangiocarcinoma
- Keywords
- FGFR2 fusion, iCCA, mixed HCC-CCA, Intrahepatic Cholangiocarcinoma, Mixed Hepatocellular Cholangiocarcinoma, Cholangiocarcinoma, ArQule
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)Industry (pharma, biotech, devices)
- Study start
- 6 Jun 2016 (actual)
- Primary completion
- 6 Apr 2017 (actual)
- Study completion
- 6 Apr 2017 (actual)
- First posted
- 5 May 2016 (estimated)
- 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.
The primary objective of this study is to estimate the frequency of FGFR2 fusions in archived intrahepatic cholangiocarcinoma (iCCA) or mixed hepatocellular-cholangiocarcinoma (HCC-CCA) tumor samples
Detailed description
This is a non-interventional, observational study of archived human tissue samples; no surgical procedures will be required and no treatment will be provided as part of this study. Approximately 150 archived tissue samples obtained from patients with iCCA or mixed HCC-CCA will be analyzed for somatic alteration status and will include cholangiocarcinoma-specific FGFR2 fusion isoforms.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- One hundred and fifty archived tumor tissue samples from patients with iCCA or mixed HCC-CCA will be collected from five to fifteen research sites in the United States and Italy and/or from commercially available sources. No new surgical procedures will be required and no treatment will be provided as part of this study.
Key inclusion criteria (4 listed)
- If required by law or local regulations (i.e., the sample is from an identifiable subject), signed written informed consent should be granted prior to use of the sample in the study
- ≥ 18 years of age
- Histologically or cytologically confirmed iCCA or mixed HCC-CCA, who are/were eligible for systemic therapy (samples collected prior to initiation of the systemic therapy may be submitted for testing)
- Have one or more formalin fixed and paraffin embedded blocks available. If blocks are not evaluable, 7-10 unstained, non-baked slides with 5-micron thick sections with at least 20% tumor tissue should be available. (Potential participants who are scheduled to undergo surgical treatment may agree to provide surplus of tissues not required for diagnosis and have to provide informed consent prior to the surgery.)
Key exclusion criteria (1 listed)
- Not applicable: Patients must meet all of the inclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Estimate the frequency of FGFR2 fusions in archived iCCA or mixed HCC-CCA tumor tissue samples
Time frame: Archived tumor samples will be collected through study completion, up to 18 months
Archived tumor samples will be collected and analyzed using a Next Generation Sequencing panel.
2 secondary outcomes
Determine the frequency of potential actionable mutations or genetic alterations in iCCA or mixed HCC-CCA
Time frame: Archived tumor samples will be collected through study completion, up to 18 months
Formulate genetic screening recommendations for newly diagnosed patients with iCCA or mixed HCC-CCA
Time frame: Archived tumor samples will be collected through study completion, up to 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2017.
Related trials for Intrahepatic Cholangiocarcinoma
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Combination Therapy Using Durvalumab and Histotripsy for Treatment of Intrahepatic Cholangiocarcinoma
Intrahepatic Cholangiocarcinoma
RecruitingPhase 3
Efficacy and Safety of Zanidatamab With Standard-of-care Therapy Against Standard-of-care Therapy for Advanced HER2-positive Biliary Tract Cancer
Biliary Tract Cancer
RecruitingPhase 2
Perioperative Retlirafusp Alfa(Anti-PD-L1/TGF-β Bifunctional Fusion Protein) Plus Famitinib and GEMOX-Based Hepatic Arterial Infusion Chemotherapy for Locally Advanced Intrahepatic Cholangiocarcinoma: A Multicenter, Single-Arm, Exploratory Phase II Trial
Intrahepatic Cholangiocarcinoma (Icc), Neoadjuvant Therapy
RecruitingPhase 2
REGULUS: MRI-guided Adaptive SABR for Liver Cancers
Liver Cancer, Intrahepatic Cholangiocarcinoma
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.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intrahepatic Cholangiocarcinoma and Mixed Hepatocellular Cholangiocarcinoma, run by ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA) at 6 sites in 2 countries.
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 4 inclusion and 1 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: finished, as of the sponsor's last update on 8 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Italy, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Estimate the frequency of FGFR2 fusions in archived iCCA or mixed HCC-CCA tumor tissue samples (time frame: Archived tumor samples will be collected through study completion, up to 18 months). 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 8 Jun 2017.