Precision Cancer Medicine for Advanced Cancer Through High-throughput Sequencing

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-11-04

Study Completion Date

2025-12-31

Brief Summary

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Precision Cancer Medicine for Advanced Cancer Through High-throughput Sequencing

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Detailed Description

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This study supports the collection of tumor specimens for CLIA-certified genomic testing and research testing in parallel. CLIA-certified tests have established measurements of accuracy and precision which allow for return of results. This study does not involve treatment, only testing, which could be used to meet eligibility criteria in other trials or therapies. This study includes a registry for longitudinal evaluation of patients whose cancer has FGFR mutations such as cholangiocarcinoma, pancreatic cancer, and others (telehealth).

Conditions

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Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Advanced Cancer Patients

Individuals with advanced or refractory cancer must be identified by study personnel or their treating physician, deemed eligible for this study, and voluntarily agree to be enrolled in this protocol through an informed consent. Biospecimen collection includes a fresh tumor biopsy, previously obtained tumor specimens or blocks (if available), whole blood, serum, plasma and buccal smear.

Biospecimen collection

Intervention Type OTHER

Specimens to be collected include a fresh tumor biopsy, previously obtained tumor specimens or blocks (if available), whole blood, serum, plasma and buccal smear.

Interventions

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Biospecimen collection

Specimens to be collected include a fresh tumor biopsy, previously obtained tumor specimens or blocks (if available), whole blood, serum, plasma and buccal smear.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. A histologically or cytologically confirmed diagnosis of cancer
2. Patients with any malignancy.
3. Patients must have tumor suitable for research tumor biopsy (as assessed by trained specialists in interventional radiology) and Patients are medically fit to undergo a tissue biopsy or surgical procedure to get tumor tissue OR If Patients do not have a tumor suitable for biopsy but have another tissue available for molecular evaluation.

OR Patients are undergoing standard of care surgeries or procedures where fresh specimens will be first used for routine pathologic assessment and only then will leftover tissue be used for research purposes.
4. Procedure-specific signed informed consent prior to initiation of any study-related procedures.
5. Women and minorities are included in this protocol.
6. Patients with multiple malignancies remain eligible.
7. Patients with an inherited cancer syndrome or a medical history suggestive of an inherited cancer syndrome remain eligible.

Exclusion Criteria

1. It is the enrolling study physicians discretion to decide if a patient is not fit enough to undergo tissue biopsy.
2. Patients who are incarcerated are not eligible to participate.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No