NCT02437617

Brief Summary

The goal of this research study is to collect and test tumor tissue from patients with advanced cancers that may be enrolled in Phase 1 studies or other treatments. Researchers will study if the results from genetic testing can help researchers determine which therapy may prove more beneficial for a patient in the future.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 13, 2012

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

May 4, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 7, 2015

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

June 14, 2021

Status Verified

June 1, 2021

Enrollment Period

8.9 years

First QC Date

May 4, 2015

Last Update Submit

June 10, 2021

Conditions

Advanced Cancers

Keywords

Advanced cancersTumor tissueGenomic profile testAnalysis of treatment outcomesMolecular profilingMolecular alteration

Outcome Measures

Primary Outcomes (1)

  • Response Rate

    Response rate of each of the three cohorts (matched targeted therapy group, control group #1 and control group #2) calculated along with its 95% confidence interval. Response rate defined as proportion of participants who experience complete response (CR) or partial response (PR). Clinical response evaluated according to the RECIST 1.1.

    6 months

Study Arms (3)

Control Group #1

Participants who have had tumor molecular analysis performed with the similar clinical characteristics and genomic aberrations but who receive therapy not matched to their aberrations, or who have received results from Foundation Medicine that fail to demonstrate any molecular alteration.

Procedure: Tumor Tissue

Control Group #2

Participants from historical archives of MD Anderson, no older than two years, who received therapy not matched to their aberrations and are matched not only on the basis of the clinical characteristics, but also, as much as possible, on the basis of genomic aberrations.

Procedure: Tumor Tissue

Matched Targeted Therapy Group

Participants with tumor aberrations who received matched targeted therapy.

Interventions

Tumor TissuePROCEDURE

Tumor tissue collected previously from surgery or a prior biopsy (archived tissue) used for genetic testing.

Control Group #1Control Group #2

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants from MDACC/Phase I historical archives, and participants actively on MDACC/Phase I studies.

You may qualify if:

  • Patients with advanced cancer.
  • Consent for use of archival tissue from primary or metastatic cancer diagnosis. Note: Patients may currently be enrolled in other investigational protocol including treatment protocols.
  • Control Group #2 only: Control Group #2 will consist of 100 patients from MDACC/Phase I historical archives. Patients (cases no older than 2 years) will be selected based on clinical characteristics and genomic alterations similar to matched targeted therapy group.
  • Patients may have received prior 'matched' therapies; however, at the time of enrollment, patients may not currently be on a known 'matched' therapy, and may not have received a 'matched' therapy as the last treatment if not receiving treatment at the time of consent.
  • Patients who have a life expectancy of greater than 3 months.

You may not qualify if:

  • Patients with advanced cancer who are NOT likely to meet the additional enrollment criteria in matched targeted therapy protocols or treatments.
  • Patients who do not have archival tissue available.
  • Patients are excluded if their last treatment before enrollment included a targeted agent matched to a genomic alteration in the patient's tumor.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

  • Wheler JJ, Janku F, Naing A, Li Y, Stephen B, Zinner R, Subbiah V, Fu S, Karp D, Falchook GS, Tsimberidou AM, Piha-Paul S, Anderson R, Ke D, Miller V, Yelensky R, Lee JJ, Hong DS, Kurzrock R. Cancer Therapy Directed by Comprehensive Genomic Profiling: A Single Center Study. Cancer Res. 2016 Jul 1;76(13):3690-701. doi: 10.1158/0008-5472.CAN-15-3043. Epub 2016 May 18.

    PMID: 27197177DERIVED

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Tumor specimens collected from patients for DNA extraction. All samples residual samples from previously performed biopsies.

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Funda Meric-Bernstam, MD

    M.D. Anderson Cancer Center

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 4, 2015

First Posted

May 7, 2015

Study Start

July 13, 2012

Primary Completion

June 1, 2021

Study Completion

June 1, 2021

Last Updated

June 14, 2021

Record last verified: 2021-06

Locations

US(1)