NCT02160366

Brief Summary

The goal of this laboratory research study is to collect and analyze treatment, molecular profiling and biomarker data. The results of the data analysis will be used to better understand how to characterize tumors and identify therapies that may be tailored to individual patients and to identify and/or predict side effects that may occur and/or predict which therapies may be best for participants. Research may also be done on your existing tissue to identify new biomarkers.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

September 27, 2010

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

June 4, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 10, 2014

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 27, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 27, 2020

Completed
Last Updated

January 10, 2020

Status Verified

January 1, 2020

Enrollment Period

10 years

First QC Date

June 4, 2014

Last Update Submit

January 8, 2020

Conditions

Keywords

Advanced CancersMolecular profilingBiomarker dataData analysisTumor marker

Outcome Measures

Primary Outcomes (1)

  • Comparison of Biomarker Profiling to Treatment Outcome

    For correlating marker profiles with response to treatment, univariate and multivariate (multiple covariates) logistic regression used, with response status taken as outcome variable. Distributions of time-to-event outcomes estimated using Kaplan-Meier curves, and these distributions compared among groups using log rank test.

    2 months

Study Arms (1)

Biomarker/Molecular Data Collection and Analyzation

Advanced cancer participants

Other: Biomarker Research

Interventions

Research studies on new biomarkers conducted on previously banked blood and/or tumor tissue. Samples collected may include blood, fresh tumor tissue, urine, saliva, bone marrow, pleural fluid, ascites, skin or hair follicle.

Biomarker/Molecular Data Collection and Analyzation

Eligibility Criteria

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

Patients referred to the Clinical Center for Targeted Therapy at UT MD Anderson Cancer Center in Houston, Texas

You may qualify if:

  • \. All patients referred to the Clinical Center for Targeted Therapy are potentially eligible for recruitment.

You may not qualify if:

  • n/a

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Publications (1)

  • Weitz J, Nishizaki D, Liau J, Patel J, Ng I, Sun S, Ramms D, Zou J, Wishart B, Rull J, Baumgartner J, Kelly K, White R, Veerapong J, Hosseini M, Patel H, Botta G, Gutkind JS, Tiriac H, Kato S, Lowy AM. Cyclin-Dependent Kinase 4/6 Inhibition as a Novel Therapy for Peritoneal Mucinous Carcinomatosis With GNAS Mutations. J Clin Oncol. 2025 Feb 20;43(6):705-715. doi: 10.1200/JCO.24.00511. Epub 2024 Oct 16.

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Samples collected may include blood, fresh tumor tissue, urine, saliva, bone marrow, pleural fluid, ascites, skin or hair follicle.

Study Officials

  • Filip Janku, MD, PHD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Filip Janku, MD, PHD

CONTACT

Study Design

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

Study Record Dates

First Submitted

June 4, 2014

First Posted

June 10, 2014

Study Start

September 27, 2010

Primary Completion

September 27, 2020

Study Completion

September 27, 2020

Last Updated

January 10, 2020

Record last verified: 2020-01

Locations