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Precision Cancer Medicine for Advanced Cancer Through High-throughput Sequencing

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02090530
Recruitment Status : Recruiting
First Posted : March 18, 2014
Last Update Posted : September 18, 2023
Sponsor:
Information provided by (Responsible Party):
Sameek Roychowdhury, Ohio State University Comprehensive Cancer Center

Study Description
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Brief Summary:
Precision Cancer Medicine for Advanced Cancer Through High-throughput Sequencing

Condition or disease Intervention/treatment
Cancer 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
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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Precision Cancer Medicine for Advanced Cancer Through High-throughput Sequencing
Actual Study Start Date : November 4, 2013
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2023
Groups and Cohorts
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Group/Cohort 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
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Primary Outcome Measures :
  1. Number of participants receiving new therapy based on study findings [ Time Frame: Up to 24 Months ]
    Impact on clinical care


Secondary Outcome Measures :
  1. Average number of days to return results [ Time Frame: Up to 24 months ]
    Determine average number of days for return of results


Biospecimen Retention:   Samples With DNA
Tumor Biopsy Whole Blood Serum Buccal Smear Plasma Formalin Fixed Paraffin Embedded (FFPE) Tissue

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with advanced or refractory cancer
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02090530


Contacts
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Contact: Ohio State University Comprehensive Cancer Center 1-800-293-5066 OSUCCCClinicaltrials@osumc.edu
Contact: Sameek Roychowdhury, MD, PhD 614-685-5842 Sameek.Roychowdhury@osumc.edu

Locations
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United States, Ohio
Ohio State University Wexner Medical Center Recruiting
Columbus, Ohio, United States, 43210
Contact: Sameek Roychowdhury, MD, PhD    614-685-5842    Sameek.Roychowdhury@osumc.edu   
Principal Investigator: Sameek Roychowdhury, MD, PhD         
Sponsors and Collaborators
Ohio State University Comprehensive Cancer Center
Investigators
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Principal Investigator: Sameek Roychowdhury, MD, PhD Ohio State University Wexner Medical Center
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Sameek Roychowdhury, Principal Investigator, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT02090530    
Other Study ID Numbers: OSU-13053
First Posted: March 18, 2014    Key Record Dates
Last Update Posted: September 18, 2023
Last Verified: September 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sameek Roychowdhury, Ohio State University Comprehensive Cancer Center:
Cancer Genomics
Tumor Sequencing