Development of a Tumor Molecular Analyses Program and Its Use to Support Treatment Decisions

NCT01457196 | Completed Results DMC

• 1 other identifier: LCCC1108
• Study Type: interventional
• Target: 2,798
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this specimen correlative study is two-fold: to provide a mechanism for the association of known molecular alterations with clinical outcomes, and to provide rapid genetic profiling of alterations with known clinical utility using tumor and germline specimens to support treatment decisions.

Conditions

Neoplasm

Keywords

Cancer Genetics

Outcome Measures

Primary Outcomes (2)

• Proportion of Patients With a Reportable Genetic Variant

  To estimate the proportion of patients enrolled on the study who have undergone successful sequencing and have a reportable genetic variant identified

  1 year

• Progression Free Survival

  Estimate Progression Free Survival (PFS) at 2 years in cancer patients with active disease with a reportable genetic variant and those without a reportable genetic variant

  2 Year

Other Outcomes (2)

• Collect and Describe Clinical Data

  1 Year

• Progression Free Survival

  1 Year

Study Arms (1)

Sequencing Arm

OTHER

Diagnostic Test: Tumor Genetic Sequencing

Interventions

Tumor Genetic Sequencing DIAGNOSTIC_TEST

This study will look at genetic material from a sample of the subjects tumor, look at certain changes in the genetic material, and see if these changes are related to the subjects cancer.

Sequencing Arm

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Current or prospective cancer patients; current cancer patients must have histologically or cytologically confirmed diagnosis of cancer
• Tumor tissue available and suitable for molecular analyses from at least one of the following sources:
• Tissue previously stored in UNC's Tissue Procurement Facility (TPF)
• Patient undergoing tissue collection as per clinical standard of care and willing to allow specimens from surplus tissue to be diverted for research purposes
• Patient undergoing tissue collection as per clinical standard of care and willing to have additional specimens taken for research
• Patient willing to undergo biopsy for purpose of research only
• ≥18 years of age
• Treatment options offer no expectation of cure, e.g., advanced solid tumor patients with metastatic disease. NOTE: This restriction applies to biopsy of vital organs only, e.g., lung, liver, etc.
• Appropriate candidate for research biopsy based on institutional standards for target biopsy site

You may not qualify if:

• Any condition that would make participation in the protocol unreasonably hazardous for the patient in the opinion of the treating physician
• Dementia, altered mental status, or any psychiatric condition or co-morbid condition that would prohibit the understanding or rendering of informed consent.
• History of serious or life-threatening allergic reaction to local anesthetics (i.e. lidocaine, xylocaine) or any medications used for conscious sedation (if applicable).
• Requires general anesthesia for collection of biopsy
• Pregnant or lactating women
• Active cardiac disease
• Patients receiving bevacizumab less than 6 weeks prior to enrollment into this study should not undergo research core biopsies because of the concern for potential increased bleeding risk and delayed healing. (NOTE: Patients receiving bevacizumab who are undergoing a research biopsy of accessible organs (e.g. breast, lymph node, skin etc.) must be two weeks from the last dose of the angiogenesis inhibitor).

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead

Study Sites (1)

University of North Carolina Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Neoplasms

Results Point of Contact

• Title: Robin Johnson
• Organization: UNC Lineberger Comprehensive Cancer Center

robin_v_johnson@med.unc.edu

919-966-1125

Study Officials

• H. Shelton Earp, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2011
• First Posted: October 21, 2011
• Study Start: September 1, 2011
• Primary Completion: June 6, 2018
• Study Completion: June 6, 2018
• Last Updated: December 30, 2019
• Results First Posted: December 30, 2019

Record last verified: 2019-12

Locations

US (1)