Precision Cancer Medicine for Advanced Cancer Through High-throughput Sequencing

The Ohio State University

Status: Enrolling

Conditions: Cancer

Treatments: Other: Biospecimen collection

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT02090530

NCI-2014-00632 (Registry Identifier)

OSU-13053

Details and patient eligibility

About

Precision Cancer Medicine for Advanced Cancer Through High-throughput Sequencing

Full description

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).

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

1,000 participants in 1 patient group

Advanced Cancer Patients

Description:

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.

Treatment:

Other: Biospecimen collection