Detection of Tumor DNA in Blood Samples From Cancer Patients

• Conditions: Cancer; Tumors
• Interventions: Diagnostic Test: Blood test

• Registration Number: NCT02288754
• Lead Sponsor: Lexent Bio, Inc.

Brief Summary

The aim of this study is to employ genomic detection methodologies to measure the relative amount of tumor nucleic acids in the blood of a cancer patient with diagnosed metastatic disease that is either commencing, currently undergoing or completed cytotoxic chemotherapy treatment. More generally, this approach will allow us to develop a quantitative measure of therapy efficacy via the counting of the relative changes in tumor molecules over the course of treatment.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-11-07
• Study First Submitted QC: 2014-11-07
• Study First Posted: 2014-11-11
• Study Start: 2014-12
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-12
• Last Update Posted: 2019-08-14
• Primary Completion: 2019-11
• Study Completion: 2020-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• Age 18 years or older
• Have metastatic disease with from a solid tumor (e.g. breast, lung, colon, pancreas, ovary, prostate...) or stage II or III solid tumors undergoing curative surgery or neoadjuvant therapy followed by surgery
• Starting treatment or a new line of treatment
• Able to understand and grant informed consent
• Able to have their blood drawn

Exclusion Criteria

• Unable to grant informed consent or comply with all study procedures.
• Has a hematological malignancy, i.e. myeloma, lymphoma, MDS, leukemia

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Metastatic disease	Blood test	Patients with advanced, recurrent and/or metastatic disease requiring systemic therapy with chemotherapy, targeted therapy, immunotherapy or a combination of any before initiation of any therapy or a new line of therapy following documentation of disease progression on prior therapy.
Stage II or III neoadjuvant therapy cohort (closed to accrual)	Blood test	Patients with stage II or III solid tumors undergoing neoadjuvant therapy followed by curative intend surgery enrolled before neoadjuvant therapy.
Stage II or III curative surgery (closed to accrual)	Blood test	Patients with stage II or III solid tumors undergoing curative intend surgery enrolled before surgery.

Primary Outcome Measures

Name	Time	Method
Correlation between the tumor load score and patient response to therapies.	5 years	Determination of a direct correlation between the tumor load score and patient response to therapies.

Secondary Outcome Measures

Name	Time	Method
Determination of particular mutation events which underlie the basis of any established correlation with therapy response.	5 years	To determine which particular mutation events underlie the basis of any established correlation with therapy response.

Trial Locations

Locations (1)

Cancer Care Associates; 🇺🇸 Torrance, California, United States