Solid TumorNCT06895681
UCSF Biobank for Hereditary Cancers and Tumor-Associated Mutations
An observational study of Solid Tumor and Solid Tumor, Adult, run by University of California, San Francisco.
Trial summary
This is a non-therapeutic clinical research biorepository protocol designed to obtain, store, and clinically annotate biospecimens from participants with hereditary cancers. Those biospecimens will be used to generate participant-derived tumor models that will serve as a resource to better understand hereditary… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor, Solid Tumor, Adult, Somatic Mutation
- What is being tested?
- Blood Sample, Tissue Sample and Excess fluid Sample
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 31 Aug 2026to 31 Dec 2035
- How long will I take part?
- 10 Years
- 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: Adults with solid tumor malignancies and germline or somatic mutations for cancer and/or a personal or family history of cancer
Who may be able to join
- For participants undergoing collection of tissue, ascites, and/or pleural effusions:
- Ability to understand and willingness to voluntarily sign a written informed consent document prior to any study-related assessments or procedures are conducted.
- Individuals 18 years of age or older on the day of signing informed consent.
- Individuals with solid tumor malignancy with germline or somatic cancer-associated mutations and/or Individuals with a family history or personal history of cancer.
- Must be planning to undergo one of the following procedures as part of their routine care (or as a research procedure under a UCSF-sponsored IIT protocol):
- Surgical resection
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- Biopsy (open, incisional, excisional, punch, core needle, and/or fine needle aspiration (FNA) are all permitted)
- Paracentesis
- Thoracentesis
- For participants undergoing blood banking:
- Ability to understand and willingness to voluntarily sign a written informed consent document prior to any study-related assessments or procedures are conducted.
- Individuals 18 years of age or older on the day of signing informed consent.
- Individuals with a family history or personal history of cancer.
- Must be planning to undergo a blood draw as part of their routine care (or as a research procedure under a University of California, San Francisco (UCSF) -sponsored investigator-initiated trial (IIT) protocol); or willing to undergo an additional blood draw outside of their routine care.
Who cannot join
- 1. Known history of HIV, Hepatitis B, or Hepatitis C (as documented in the medical record) or other infectious disease that in the judgment of the investigator could pose a risk to research personnel or mice, or negatively impact Patient derived xenografts (PDX) tumor engraftment.
About this study
Official title: UCSF Biobank for Studying Hereditary Cancers and Tumor-Associated Mutations
This is a non-therapeutic clinical research biorepository protocol designed to obtain, store, and clinically annotate biospecimens from participants with hereditary cancers. Those biospecimens will be used to generate participant-derived tumor models that will serve as a resource to better understand hereditary cancers and develop new efficient therapies.
Read the detailed description
Primary Objective:
- To generate a repository of participant-derived tumor models* and specimens** - annotated with demographic, clinical, and pathologic data - from adults with solid tumor malignancies with germline or somatic tumor-associated mutations and/or a personal or family history of cancer.
- Participant-derived models may include (but are not limited to) xenografts (PDX), organoids (PDO), and cell lines (PDCLs).
- Specimens may include tissue, ascites and pleural fluid, and blood.
Exploratory Objectives
- To correlate in vivo drug sensitivity of participant-derived models with patient clinical response.
- To conduct blood-based assessment of tumor-associated biomarkers (DNA/RNA/protein, etc.).
- To describe tumor and blood-based biomarkers that are predictive of clinical response.
- To correlate changes in tumor and blood-based biomarker expression with clinical outcomes over time.
- To perform genomic and transcriptomic profiling of banked specimens and correlate findings with clinical outcomes, prognostic markers, and biomarkers.
- Unspecified cancer-centric research in the Munster Lab and other future unspecified research.
OUTLINE:
Participants will have biospecimens collected at non-study, routine procedures or visits to be stored at UCSF. Specimens will be processed and banked as per standard operating procedure. Participants will be followed through medical record chart review for a period of 10 years after signing informed consent, and be contacted every 3 months (± 2 months) for the first year and every 6 months (± 3 months) thereafter to allow updates to health status.
- Conditions
- Solid Tumor, Solid Tumor, Adult, Somatic Mutation, Solid Tumor, Unspecified, Adult, Hereditary Cancer
- Being tested
- Blood Sample, Tissue Sample, Excess fluid Sample, Medical Chart Review
- Keywords
- Germline Mutations, Tumor-Associated Mutations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood SampleProcedure or surgery
Also called Blood Specimen
Obtained at the time of non-study related routine blood draw.
Tissue SampleProcedure or surgery
Also called Tissue Specimen
Obtained at the time of non-study related routine biopsy or surgical procedure.
Excess fluid SampleProcedure or surgery
Obtained at the time of non-study related routine biopsy, surgical procedure, paracentesis, or thoracentesis procedure.
Medical Chart ReviewOther
Also called Medical Record Review
Demographic, clinical, and pathologic information will be extracted from the medical record
| Study group | Role | What they receive |
|---|---|---|
| Adults with solid tumor malignancies | Participants' biospecimen samples (Tissue, Excess fluid (i.e., ascites, pleural effusions, and Blood) will be obtained during non-study, routine medical visits whenever possible, to minimize participant risk. Blood samples will be collected up to 5 times from consenting participants. Receives: Procedure: Blood Sample; Procedure: Tissue Sample; Procedure: Excess fluid Sample; Other: Medical Chart Review |
What is being measured
The primary outcome is the main question the study is designed to answer.
Develop participant-derived tumor models of hereditary cancers
Participant-derived models may include (but are not limited to) xenografts (PDX), organoids (PDO), and cell lines (PDCLs). These models recapitulate the biology and tissue context of the original tumors from which they are derived and can be used to study effective therapeutic strategies.
Measured: Up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2025
- Study start31 Aug 2026 (estimated)
- Primary completion31 Dec 2035 (estimated)
- Study completion31 Dec 2035 (estimated)
Why it stopped: IRB study closure
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Varun Monga, MBBS, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06895681
- Sponsor's protocol ID
- 24986
- Status last verified
- Aug 2026
- First submitted
- 19 Mar 2025
- Last updated
- 2 Sep 2026
- 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 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- UCSF Biobank for Studying Hereditary Cancers and Tumor-Associated Mutations
- ClinicalTrials.gov ID
- NCT06895681
- Acronym / sponsor ID
- 24986
- Conditions
- Solid Tumor, Solid Tumor, Adult, Somatic Mutation, Solid Tumor, Unspecified, Adult, Hereditary Cancer
- Keywords
- Germline Mutations, Tumor-Associated Mutations
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: IRB study closure
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 31 Aug 2026 (estimated)
- Primary completion
- 31 Dec 2035 (estimated)
- Study completion
- 31 Dec 2035 (estimated)
- First posted
- 26 Mar 2025 (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 non-therapeutic clinical research biorepository protocol designed to obtain, store, and clinically annotate biospecimens from participants with hereditary cancers. Those biospecimens will be used to generate participant-derived tumor models that will serve as a resource to better understand hereditary cancers and develop new efficient therapies.
Detailed description
Primary Objective:
- To generate a repository of participant-derived tumor models* and specimens** - annotated with demographic, clinical, and pathologic data - from adults with solid tumor malignancies with germline or somatic tumor-associated mutations and/or a personal or family history of cancer.
- Participant-derived models may include (but are not limited to) xenografts (PDX), organoids (PDO), and cell lines (PDCLs).
- Specimens may include tissue, ascites and pleural fluid, and blood.
Exploratory Objectives
- To correlate in vivo drug sensitivity of participant-derived models with patient clinical response.
- To conduct blood-based assessment of tumor-associated biomarkers (DNA/RNA/protein, etc.).
- To describe tumor and blood-based biomarkers that are predictive of clinical response.
- To correlate changes in tumor and blood-based biomarker expression with clinical outcomes over time.
- To perform genomic and transcriptomic profiling of banked specimens and correlate findings with clinical outcomes, prognostic markers, and biomarkers.
- Unspecified cancer-centric research in the Munster Lab and other future unspecified research.
OUTLINE:
Participants will have biospecimens collected at non-study, routine procedures or visits to be stored at UCSF. Specimens will be processed and banked as per standard operating procedure. Participants will be followed through medical record chart review for a period of 10 years after signing informed consent, and be contacted every 3 months (± 2 months) for the first year and every 6 months (± 3 months) thereafter to allow updates to health status.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults with solid tumor malignancies | – | Procedure: Blood Sample, Procedure: Tissue Sample, Procedure: Excess fluid Sample, Other: Medical Chart ReviewParticipants' biospecimen samples (Tissue, Excess fluid (i.e., ascites, pleural effusions, and Blood) will be obtained during non-study, routine medical visits whenever possible, to minimize participant risk. Blood samples will be collected up to 5 times from consenting participants. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with solid tumor malignancies and germline or somatic mutations for cancer and/or a personal or family history of cancer
Key inclusion criteria (14 listed)
- Ability to understand and willingness to voluntarily sign a written informed consent document prior to any study-related assessments or procedures are conducted.
- Individuals 18 years of age or older on the day of signing informed consent.
- Individuals with solid tumor malignancy with germline or somatic cancer-associated mutations and/or Individuals with a family history or personal history of cancer.
- Must be planning to undergo one of the following procedures as part of their routine care (or as a research procedure under a UCSF-sponsored IIT protocol):
- Ability to understand and willingness to voluntarily sign a written informed consent document prior to any study-related assessments or procedures are conducted.
Key exclusion criteria (1 listed)
- 1. Known history of HIV, Hepatitis B, or Hepatitis C (as documented in the medical record) or other infectious disease that in the judgment of the investigator could pose a risk to research personnel or mice, or negatively impact Patient derived xenografts (PDX) tumor engraftment.
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 |
|---|---|---|
| Blood SampleAlso: Blood SpecimenObtained at the time of non-study related routine blood draw. | Procedure or surgery | Adults with solid tumor malignancies |
| Tissue SampleAlso: Tissue SpecimenObtained at the time of non-study related routine biopsy or surgical procedure. | Procedure or surgery | Adults with solid tumor malignancies |
| Excess fluid SampleObtained at the time of non-study related routine biopsy, surgical procedure, paracentesis, or thoracentesis procedure. | Procedure or surgery | Adults with solid tumor malignancies |
| Medical Chart ReviewAlso: Medical Record ReviewDemographic, clinical, and pathologic information will be extracted from the medical record | Other | Adults with solid tumor malignancies |
Primary outcome
Develop participant-derived tumor models of hereditary cancers
Time frame: Up to 10 years
Participant-derived models may include (but are not limited to) xenografts (PDX), organoids (PDO), and cell lines (PDCLs). These models recapitulate the biology and tissue context of the original tumors from which they are derived and can be used to study effective therapeutic strategies.
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 2 Sep 2026.
- 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.
Varun Monga, MBBS principal investigator
University of California, San Francisco
Questions about this trial
What is this clinical trial studying?
An observational study of Solid Tumor and Solid Tumor, Adult, run by University of California, San Francisco.
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 14 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: withdrawn, as of the sponsor's last update on 2 Sep 2026. 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?
Develop participant-derived tumor models of hereditary cancers (time frame: Up to 10 years). 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 2 Sep 2026.