RECRUITING

Specimen Collection from Patients with Non-Hematologic Cancer for Use in Development of a Liquid Biopsy Assay

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Conditions

Non-hematologic Cancer

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This specimen collection is designed to obtain whole blood and tumor tissue from subjects diagnosed with cancer for the purpose of the development of a noninvasive liquid biopsy assay using next generation sequencing (NGS).

Official Title

Collection of Whole Blood and Tissue Specimens from Patients Diagnosed with Non-Hematologic Cancer for Use in Development of a Noninvasive Liquid Biopsy Assay to Determine the Tumor Genomic Profile in Circulating Cell-Free Tumor DNA

Quick Facts

Study Start:2015-10-13
Study Completion:2027-10-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT02586389

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Subject is 18 years of age or older;
  2. * Subject is willing to provide written informed consent;
  3. * Subject has a diagnosis of a non-hematologic cancer, has tumor in the body, and has either;
  4. 1. residual tumor tissue available for testing by the Sponsor; or
  5. 2. genomic profiling results from an IVD or LDT assay performed on tumor biopsy tissue; or
  6. 3. an invasive procedure (biopsy, surgery) scheduled following the Baseline Visit from which residual tumor tissue can be available for testing by the Sponsor.
  7. * Subject is able, in the professional opinion of the investigator, to provide whole blood at the Baseline Visit and at the Interim Visits.
  1. * Underwent curative-intent surgery for management of the presently diagnosed tumor, at any time prior to the Baseline Visit.
  2. * Underwent targeted or non-targeted chemotherapy, hormone receptor blocking therapy, or radiation therapy prior to the Baseline Visit.
  3. * Underwent an invasive procedure (biopsy, surgery, thermal ablation) in the 7 days prior to any blood collection (baseline or follow-up).
  4. * Any medical or mental condition that would interfere with the subjects' ability to willingly give written informed consent.

Contacts and Locations

Study Contact

Graham McLennan
CONTACT
(858) 202-9162
gmclennan@sequenom.com

Principal Investigator

Sue Beruti, MD
STUDY_DIRECTOR
Sequenom, Inc.

Study Locations (Sites)

Idaho Urology
Boise, Idaho
United States

Collaborators and Investigators

Sponsor: Sequenom, Inc.

  • Sue Beruti, MD, STUDY_DIRECTOR, Sequenom, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2015-10-13
Study Completion Date2027-10-31

Study Record Updates

Study Start Date2015-10-13
Study Completion Date2027-10-31

Terms related to this study

Additional Relevant MeSH Terms

  • Non-hematologic Cancer