Precision Cancer Medicine for Advanced Cancer Through High-throughput Sequencing

Overview

Precision Cancer Medicine for Advanced Cancer Through High-throughput Sequencing

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: December 31, 2023

Detailed 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.

Interventions

  • Other: 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.

Arms, Groups and Cohorts

  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Number of participants receiving new therapy based on study findings
    • Time Frame: Up to 24 Months
    • Impact on clinical care

Secondary Measures

  • Average number of days to return results
    • Time Frame: Up to 24 months
    • Determine average number of days for return of results

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Ohio State University Comprehensive Cancer Center
  • Provider of Information About this Clinical Study
    • Principal Investigator: Sameek Roychowdhury, Principal Investigator – Ohio State University Comprehensive Cancer Center
  • Overall Official(s)
    • Sameek Roychowdhury, MD, PhD, Principal Investigator, Ohio State University Wexner Medical Center
  • Overall Contact(s)
    • Ohio State University Comprehensive Cancer Center, 1-800-293-5066, OSUCCCClinicaltrials@osumc.edu

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