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

Neoplasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01457196
• Other study ID #: LCCC1108
• Status: Completed
• Phase: N/A
• Start date: September 2011
• Est. completion date: June 6, 2018

Study information

• Verified date: December 2019
• Source: UNC Lineberger Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2798
• Est. completion date: June 6, 2018
• Est. primary completion date: June 6, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. Current or prospective cancer patients; current cancer patients must have histologically or cytologically confirmed diagnosis of cancer

2. 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)

• Tissue previous stored at an institution other than UNC-CH, provided investigators can determine that the tumors were sampled and stored under appropriate conditions for inclusion in the study

• 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

3. The following inclusion criteria apply only to patients undergoing biopsy for research purposes only under this protocol:

• =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

Exclusion Criteria:

1. Any condition that would make participation in the protocol unreasonably hazardous for the patient in the opinion of the treating physician

2. Dementia, altered mental status, or any psychiatric condition or co-morbid condition that would prohibit the understanding or rendering of informed consent.

3. The following exclusion criteria apply only to enrolled patients undergoing biopsy for research purposes only:

4. History of serious or life-threatening allergic reaction to local anesthetics (i.e. lidocaine, xylocaine) or any medications used for conscious sedation (if applicable).

5. Requires general anesthesia for collection of biopsy

6. Pregnant or lactating women

7. Active cardiac disease

8. 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).

Related Conditions & MeSH terms

• Neoplasm

Intervention

Diagnostic Test:
• Tumor Genetic Sequencing
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.

Locations

Country	Name	City	State
United States	University of North Carolina Lineberger Comprehensive Cancer Center	Chapel Hill	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
UNC Lineberger Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Collect and Describe Clinical Data	To collect and describe clinical data including treatment outcomes after availability of results in patients	1 Year
Other	Progression Free Survival	To compare progression free survival ratios between cancer patients with active disease with reportable genetic variant who were treated based on variant and those who were not treated based on a variant	1 Year
Primary	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
Primary	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