Biopsies of Cancer Patients for Tumor Molecular Characterization

NCT01061944 | Completed DMC

• 1 other identifier: 09-369
• Study Type: observational
• Target: 188
• Locations: 1 country
• Sites: 1

Brief Summary

In this research study, we are looking at performing a repeat biopsy of patients' tumors, even though they have already been diagnosed with cancer. The tumor tissue obtained from the biopsy will be studied to see what it looks like at the molecular (genetic) level. By conducting this study, we hope to learn more about how cancers work, why cancers respond to certain treatments, and how they become resistant to certain treatments. We also hope to demonstrate that biopsies like this can be performed safely in large numbers of patients. The research done on the tumor samples may help us identify which patients in the future are most likely to respond to new cancer therapies.

Conditions

Cancer; Metastatic Cancer

Keywords

biopsy; tumor biopsy; genetic studies

Outcome Measures

Primary Outcomes (1)

• To determine the feasibility and safety of repeat biopsies for molecular characterization.

  2 years

Secondary Outcomes (2)

• To determine the somatic genotype of cancer patients with acquired resistance to a targeted therapy, and to compare these findings with pre-treatment genomic profiled from the same patients.

  2 years

• To estimate the success rate of molecular diagnostics from biopsies specifically obtained for such testing.

  2 years

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

Patients will be identified by their oncologist and the service performing the biopsy as a good candidate for the repeat tumor biopsy procedure. Review of the medical record and laboratory data is also performed to ensure the risks of complications are reasonable low and within standard parameters.

You may qualify if:

• Patients must already be known to have metastatic, incurable cancer.
• Patients must have been referred for repeat tumor biopsy as part of standard care and biopsy must have been approved by the appropriate biopsy service (interventional radiology or surgery). Such approval includes review of medical history and laboratory parameters as per standard care.
• years of age or older
• Patients must have previously responded to a molecularly-targeted therapy and subsequently developed resistance, or have an analogous clinical situation in which determining their molecular genotype is of interest clinically and/or scientifically.

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Tumor biopsy

MeSH Terms

Conditions

Neoplasms; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Lecia V. Sequist, MD, MPH

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 2, 2010
• First Posted: February 3, 2010
• Study Start: February 1, 2010
• Primary Completion: December 1, 2016
• Study Completion: January 1, 2018
• Last Updated: January 26, 2018

Record last verified: 2018-01

Locations

US (1)