Precision Cancer Medicine for Advanced Cancer Through High-throughput Sequencing

Sponsor
Ohio State University Comprehensive Cancer Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT02090530
Collaborator
(none)
400
1
109.9
3.6

Study Details

Study Description

Brief Summary

Precision Cancer Medicine for Advanced Cancer Through High-throughput Sequencing

Condition or Disease Intervention/Treatment Phase
  • Other: Biospecimen collection

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
400 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Precision Cancer Medicine for Advanced Cancer Through High-throughput Sequencing
Actual Study Start Date :
Nov 4, 2013
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm Intervention/Treatment
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.

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.

Outcome Measures

Primary Outcome Measures

  1. Number of participants receiving new therapy based on study findings [Up to 24 Months]

    Impact on clinical care

Secondary Outcome Measures

  1. Average number of days to return results [Up to 24 months]

    Determine average number of days for return of results

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

  1. Procedure-specific signed informed consent prior to initiation of any study-related procedures.

  2. Women and minorities are included in this protocol.

  3. Patients with multiple malignancies remain eligible.

  4. 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ohio State University Wexner Medical Center Columbus Ohio United States 43210

Sponsors and Collaborators

  • Ohio State University Comprehensive Cancer Center

Investigators

  • Principal Investigator: Sameek Roychowdhury, MD, PhD, Ohio State University Wexner Medical Center

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Sameek Roychowdhury, Principal Investigator, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT02090530
Other Study ID Numbers:
  • OSU-13053
First Posted:
Mar 18, 2014
Last Update Posted:
Feb 17, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Sameek Roychowdhury, Principal Investigator, Ohio State University Comprehensive Cancer Center

Study Results

No Results Posted as of Feb 17, 2022