Characterization of Human Cancers by Molecular Profiling of Patient Biospecimens

NCT02749838 | Unknown

• 1 other identifier: PI-13-1008
• Study Type: observational
• Target: 183
• Locations: 1 country
• Sites: 1

Brief Summary

Purpose of the Protocol:

• To prospectively identify cancer patients whose tumors express specific molecular markers targeted by therapeutic agents, for the purpose of selecting the most clinically appropriate anticancer therapy, including clinical trial opportunities.
• To collect and analyze biospecimens from cancer patients, using primarily standard of care laboratory methods, for the purpose of determining the expression of specific genotypic and phenotypic disease markers of scientific and medical interest.
• To create a protocol database, including case and disease stage-matched clinical and therapeutic history data in addition to patient biomarker profiles, to serve as:
• a systematic collection of data for comparing patient data to clinical trial selection criteria for the purpose of informing a clinical investigative site of available clinical trials matching patient clinical status;
• a collection of clinically matched, comprehensive molecular results for scientific and research and development applications.

Conditions

Cancer

Keywords

Cancer; Genomic testing; Genetic testing; Molecular screening; Molecular Profiling; Biomarker; Biopsy; Tumor sampling; Registry

Outcome Measures

Primary Outcomes (1)

• Identification of oncogenic molecular abnormalities by laboratory testing of tumor tissue

  60 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

There are no restrictions on number, gender, or racial/ethnic orgin of patients enrolled in this study.

You may qualify if:

• Patients who have given informed consent in accordance with the methods and procedures of this study
• Diagnosis of cancer requiring medical care
• Age ≥18 years
• Patients under oncology care of a participating site
• ECOG performance status of 0-3
• Sufficient clinical status for collection of biospecimen samples within usual care

You may not qualify if:

• Patients considered minors in the jurisdiction where the protocol is conducted
• Patients who are prisoners
• Patients who are employees of the research site
• Relatives of the principal investigator or any participating physician
• Patients with decisional incapacity who cannot understand or comprehend the informed consent form and therefore cannot give informed consent

Sponsors & Collaborators

• Pharmatech: lead
• Paradigm: collaborator

Study Sites (1)

Pharmatech Inc.

Denver, Colorado, 80203, United States

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Matthew B Wiener, PharmD

  Pharmatech Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2014
• First Posted: April 25, 2016
• Study Start: May 1, 2014
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: April 25, 2016

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)