An Ancillary Pilot Trial Using Whole Genome Sequencing In Patients With Advance Refractory Cancer

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

11 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-09-30

Study Completion Date

2013-03-31

Brief Summary

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

When a patient with advanced cancer consults with a member of the Phase I drug development team, the investigators utilize all information possible to try to select a therapy for that patient which has the best chance of working for them. This information includes:

1. Past published information
2. Clinical experience and judgement
3. Immunohistochemistry for specific targets (e.g., ER)
4. Standard sequencing (e.g., for K-Ras) and other methods now available.

The investigators have a new tool which warrants early exploration for what role it might eventually play in the process of selecting the best therapy for an individual patient. The basis of the current ancillary exploratory study is to gain initial experience with the operational aspects of this whole genome sequencing in this setting.

Related Clinical Trials

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

Collecting Blood Samples From Patients With and Without Cancer to Evaluate Tests for Early Cancer Detection

NCT05334069

Acute Lymphoblastic Leukemia Acute Myeloid Leukemia Ann Arbor Stage I Lymphoma +59 more

RECRUITING

Next-generation Sequencing of Small Cell Lung Cancer to Identify Actionable Targets for Treatment

NCT02297087

Small Cell Lung Cancer

TERMINATED NA

Tumor Collection From Routine Nephrectomy for Subjects With Advanced Stage RCC

NCT02143492

Kidney Cancer Renal Cell Carcinoma Advanced Renal Cell Carcinoma

COMPLETED

Studying Biomarkers in Tumor Tissue and Blood Samples From Patients With Small Cell Lung Cancer Registered on CALGB-140202

NCT01503619

Lung Cancer

COMPLETED

HER-2 Mutations in Tumor Samples From Patients With Advanced Non-Small Cell Lung Cancer Treated on Clinical Trial ECOG-2598

NCT00896909

Lung Cancer

COMPLETED

Detailed Description

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

1. To measure the time from biopsy to completion and final analysis of Whole Genome Sequencing (WGS) on patient tumor and non-tumor samples.
2. To examine the frequency with which useable sequence data is obtained as a function of tumor volume received and percent tumor involvement in the biopsy
3. To identify the frequency with which potential targets and pathways for therapy are discovered.
4. To observe for any evidence that if anti-tumor activity from treatment is noted how would the genome sequencing have correlated with that activity.

Conditions

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

Advanced Cancer

Eligibility Criteria

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

Inclusion Criteria

* Have a life expectancy of greater than 3 months.
* Patients must have a diagnosis of histologically or cytologically confirmed advanced incurable cancer which has progressed on one or more prior chemotherapeutic, hormonal or biological regimens for advanced disease.
* Be a good medical candidate for and willing to undergo a biopsy or surgical procedure to obtain tissue, which may or may not be part of the patient's routine care for their malignancy.

Exclusion Criteria

* Patients with symptomatic CNS metastasis.
* Known HIV, HBV or HCV infection requiring antiviral therapy.
* Pregnant or breast-feeding patients or any patient with childbearing potential not using adequate contraception.
* Inaccessible tumor for biopsy

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No