Detection of Tumor DNA in Blood Samples From Cancer Patients

Lexent Bio

Status: Unknown

Conditions: Tumors; Cancer

Treatments: Diagnostic Test: Blood test

Study type: Observational

Funder types: Industry

Identifiers

NCT02288754

LB1985106

Details and patient eligibility

About

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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

500 participants in 3 patient groups

Stage II or III curative surgery (closed to accrual)

Description:

Patients with stage II or III solid tumors undergoing curative intend surgery enrolled before surgery.

Treatment:

Diagnostic Test: Blood test

Stage II or III neoadjuvant therapy cohort (closed to accrual)

Description:

Patients with stage II or III solid tumors undergoing neoadjuvant therapy followed by curative intend surgery enrolled before neoadjuvant therapy.

Treatment:

Diagnostic Test: Blood test

Metastatic disease

Description:

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.

Treatment:

Diagnostic Test: Blood test