We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Precision Cancer Medicine for Advanced Cancer Through High-throughput Sequencing

This study is currently recruiting participants.
Verified October 2016 by Sameek Roychowdhury, Ohio State University Comprehensive Cancer Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT02090530
First Posted: March 18, 2014
Last Update Posted: October 21, 2016
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.
Information provided by (Responsible Party):
Sameek Roychowdhury, Ohio State University Comprehensive Cancer Center
  Purpose
Precision Cancer Medicine for Advanced Cancer Through High-throughput Sequencing

Condition Intervention
Cancer Other: Biospecimen collection

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Precision Cancer Medicine for Advanced Cancer Through High-throughput Sequencing

Further study details as provided by Sameek Roychowdhury, Ohio State University Comprehensive Cancer Center:

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


Secondary Outcome Measures:
  • 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

Estimated Enrollment: 400
Study Start Date: November 2013
Estimated Study Completion Date: February 2018
Estimated Primary Completion Date: February 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
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
Contact: Ohio State University Comprehensive Cancer Center 1-800-293-5066 Jamesline@osumc.edu
Contact: Sameek Roychowdhury, MD, PhD 614-685-5842 Sameek.Roychowdhury@osumc.edu

Locations
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
Principal Investigator: Sameek Roychowdhury, MD, PhD Ohio State University Wexner Medical Center
  More Information

Additional Information:
Responsible Party: Sameek Roychowdhury, Principal Investigator, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT02090530     History of Changes
Other Study ID Numbers: OSU-13053
First Submitted: March 7, 2014
First Posted: March 18, 2014
Last Update Posted: October 21, 2016
Last Verified: October 2016

Keywords provided by Sameek Roychowdhury, Ohio State University Comprehensive Cancer Center:
Cancer Genomics
Tumor Sequencing