Gallbladder CarcinomaNCT05222854
Comprehensive Genomic Profiling Combined With Real Life Data of "The German-Registry of Incidental Gallbladder Carcinoma"
An observational study of Gallbladder Carcinoma, run by Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest at 1 site in Germany.
Trial summary
Multicenter German- Registry of Incidental Gallbladder Carcinoma combining clinical real-world data and comprehensive genomic profiling. The registry collects medical data from clinical observation and molecular data derived from archival tumor tissue samples but does not define any medical intervention nor does it… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gallbladder Carcinoma
- How many people
- 200 participants
- Where
- 1 siteGermany
- Study dates
- 11 Oct 2017to Dec 2099
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Adult, Older adult
Study population: adult patients with gallbladder carcinoma
Who may be able to join
- Histologically confirmed diagnosis of incidental gallbladder carcinoma
- Patient ≥ 18 years old
- Patient already deceased
- Available tumor tissue (FFPE block)
Who cannot join
- Patient under 18 years of age
Trial locations and contacts
1 site in 1 country.
Germany1 site
Frankfurter Institut für Klinische Krebsforschung IKF GmbH
Frankfurt am Main, 60488
About this study
Official title: Comprehensive Genomic Profiling Combined With Real Life Data of "The German-Registry of Incidental Gallbladder Carcinoma" the CONGENIAL Analysis Sub-study of the GR
Multicenter German- Registry of Incidental Gallbladder Carcinoma combining clinical real-world data and comprehensive genomic profiling. The registry collects medical data from clinical observation and molecular data derived from archival tumor tissue samples but does not define any medical intervention nor does it evaluate the efficacy or safety of the treatment decision made by the investigator.
Read the detailed description
In the largest cohort of IGBC patients ever analysed in such a comprehensive approach
- determine the course of patients in this rare kind of cancer
- combine cGP analysis of histological tumor samples with clinical real-life data to get a comprehensive overview on IGBC patients analysed and evaluate data to identify possible further (targeted) treatment possibilities
- analyze potential risk factors associated with gallbladder carcinoma
- assess the frequency of targetable mutations in IGBC
- Conditions
- Gallbladder Carcinoma
- Medical subject headings
- Gallbladder Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival
Overall Survival is defined as the time from date of first surgery, to the date of death (due to any cause).
Measured: Through study completion, an average of 2 years
proportion of patients with genomic alterations
The primary outcome variable of the molecular sub-project is the proportion of patients with actionable genomic alterations, defined as number of patients with actionable mutations divided by the number of patients with completed F1 CDx testing. Additionally, the two-sided 95% exact confidence interval (Clopper-Pearson) will be given.
Measured: Through study completion, an average of 2 years
Secondary outcomes (1)
The proportion of patients with actionable genomic alterations in all patients
The proportion of patients with actionable genomic alterations in all patients, including those where no FoundationOne CDx test result may be obtained ± 95% confidence interval
Measured: Through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2022
- Study start11 Oct 2017
- Primary completionJun 2024 (estimated)
- Study completionDec 2099 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gallbladder CarcinomaStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thorsten Götze, Prof., Principal investigator, Institute of clinical cancer research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05222854
- Sponsor's protocol ID
- CONGENIAL
- Status last verified
- Mar 2024
- First submitted
- 22 Dec 2021
- Last updated
- 6 Mar 2024
- 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 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Genomic Profiling Combined With Real Life Data of "The German-Registry of Incidental Gallbladder Carcinoma" the CONGENIAL Analysis Sub-study of the GR
- ClinicalTrials.gov ID
- NCT05222854
- Acronym / sponsor ID
- CONGENIAL
- Conditions
- Gallbladder Carcinoma
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus NordwestUniversity, hospital or other
- Study start
- 11 Oct 2017 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Dec 2099 (estimated)
- First posted
- 3 Feb 2022 (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.
Multicenter German- Registry of Incidental Gallbladder Carcinoma combining clinical real-world data and comprehensive genomic profiling. The registry collects medical data from clinical observation and molecular data derived from archival tumor tissue samples but does not define any medical intervention nor does it evaluate the efficacy or safety of the treatment decision made by the investigator.
Detailed description
In the largest cohort of IGBC patients ever analysed in such a comprehensive approach
- determine the course of patients in this rare kind of cancer
- combine cGP analysis of histological tumor samples with clinical real-life data to get a comprehensive overview on IGBC patients analysed and evaluate data to identify possible further (targeted) treatment possibilities
- analyze potential risk factors associated with gallbladder carcinoma
- assess the frequency of targetable mutations in IGBC
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- adult patients with gallbladder carcinoma
Key inclusion criteria (4 listed)
- Histologically confirmed diagnosis of incidental gallbladder carcinoma
- Patient ≥ 18 years old
- Patient already deceased
- Available tumor tissue (FFPE block)
Key exclusion criteria (1 listed)
- Patient under 18 years of age
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
overall survival
Time frame: Through study completion, an average of 2 years
Overall Survival is defined as the time from date of first surgery, to the date of death (due to any cause).
proportion of patients with genomic alterations
Time frame: Through study completion, an average of 2 years
The primary outcome variable of the molecular sub-project is the proportion of patients with actionable genomic alterations, defined as number of patients with actionable mutations divided by the number of patients with completed F1 CDx testing. Additionally, the two-sided 95% exact confidence interval (Clopper-Pearson) will be given.
1 secondary outcome
The proportion of patients with actionable genomic alterations in all patients
Time frame: Through study completion, an average of 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
- 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.
Thorsten Götze, Prof. principal investigator
Institute of clinical cancer research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gallbladder Carcinoma, run by Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest at 1 site in Germany.
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: under way, not looking for participants, as of the sponsor's last update on 6 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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?
This study is still under way. Results are not available in the source record yet.
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?
overall survival (time frame: Through study completion, an average of 2 years). The study lists 2 primary outcomes in all. 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 6 Mar 2024.