Detection of Oncogenic Tumor Mutations in the Urine and Blood of Lung and Colorectal Cancer Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

84 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to see whether gene mutations can be found in the urine or blood of lung cancer patients and urine of colorectal cancer patients. Gene mutations are when DNA in a gene is damaged in a way that changes the genetic message carried by that gene. Gene mutations can sometimes cause lung cancers. These gene mutations are only found in lung and colorectal cancer cells, not the normal cells in your body. All lung cancer tumors and colorectal cancer tumors are now tested for different gene mutations as their presence affects lung cancer treatment. Tumor samples obtained from a biopsy or surgery are typically tested for these gene mutations.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Tumor Cell and DNA Detection in the Blood, Urine and Bone Marrow of Patients With Solid Cancers

NCT02838836

Non-small Cell Lung Cancer Esophageal Cancer Gastric Cancer +3 more

RECRUITING

DNA Repair and Genetic Susceptibility to Lung Cancer

NCT00611598

Lung Cancer Single Primary Lung Cancer Second Primary Lung Cancer

COMPLETED

A Genotype-Phenotype Urothelial Cancer Registry

NCT00902590

Urothelial Cancer Renal Pelvis Cancer Ureter Cancer +1 more

ACTIVE_NOT_RECRUITING

A 12-Gene Blood-Based Signature for Detecting Metastatic Bladder Cancer

NCT00918008

Bladder Cancer

TERMINATED

Biomarker Identification for Bladder Cancer Patients

NCT02053662

Bladder Cancer

TERMINATED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Lung Cancer Colorectal Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Lung and Colorectal cancer patients

Eligible people who consent to participation will provide urine (both in lung cancer and colorectal cancer) and blood (in lung cancer only) samples at pre-specified times.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

Lung cancer:

For patients participating in Part A (initial testing) and Part B (serial testing):

* Patients must have a diagnosis of stage IV lung adenocarcinoma undergoing systemic therapy.
* Patients must have had or intend to have EGFR mutation testing (specifically including exon 19 deletions and L858R) performed on their tumor with results available from a CLIA certified laboratory.
* ≥ 18 years of age

Specific to patients participating in Part B (serial testing):

* Patients must be planning to receive cancer care at Memorial-Sloan Kettering.
* Patients must have a confirmed EGFR mutant lung cancer (exon 19 deletions and L858R) with molecular testing results available from a CLIA certified laboratory.
* Must be within 3 months of their diagnosis of metastatic lung cancer.
* Treatment plan should include an EGFR tyrosine kinase inhibitor, but may concurrently be on a therapeutic protocol.

Colorectal Cancer:

For patients participating in Part A (initial testing) and Part B (serial testing):

* Patients must have a diagnosis of stage IV colorectal adenocarcinoma undergoing systemic therapy or have recently progressed on therapy including anti-EGFR based therapy.
* Patients must have had or intend to have RAS/RAF mutation testing on their tumor with results available from a CLIA certified laboratory. For the patients who recently progressed on anti-EGFR must have tumor tissue molecular analyses preformed (prior to enrolling or a plan to test it at the time of enrollment).
* \>18 years of age

Specific to patients participating in Part B (serial testing):

* Patients must be planning to receive cancer care at Memorial-Sloan Kettering.
* Patients must have a confirmed RAS/RAF mutant colorectal cancer with molecular testing results available from a CLIA certified laboratory.
* Must be within 3 months of their diagnosis of metastatic colorectal cancer.