Detection of Tumor DNA in Blood Samples From Cancer Patients

NCT02288754 | Unknown DMC

• 1 other identifier: LB1985106
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer; Tumors

Keywords

DNA in Tumors; cfDNA; WGS; Advanced stage cancer; Solid tumors

Outcome Measures

Primary Outcomes (1)

• Correlation between the tumor load score and patient response to therapies.

  Determination of a direct correlation between the tumor load score and patient response to therapies.

  5 years

Secondary Outcomes (1)

• Determination of particular mutation events which underlie the basis of any established correlation with therapy response.

  5 years

Study Arms (3)

Stage II or III curative surgery (closed to accrual)

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

Diagnostic Test: Blood test

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

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

Diagnostic Test: Blood test

Metastatic disease

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.

Diagnostic Test: Blood test

Interventions

Blood test DIAGNOSTIC_TEST

No intervention except to collect blood for diagnostic test development

Metastatic disease; Stage II or III curative surgery (closed to accrual); Stage II or III neoadjuvant therapy cohort (closed to accrual)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who are (i) commencing or (ii) starting a new line of treatment for metastatic disease with any cytotoxic chemotherapy, targeted therapy, immunotherapy, a combination of any and/or radiation therapy. Patients with stage II or III solid tumors undergoing curative intend surgery or neoadjuvant therapy followed by surgery are also eligible, before surgery or initiation of neoadjuvant therapy.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Lexent Bio, Inc.: lead

Study Sites (1)

Cancer Care Associates

Torrance, California, 90277, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood 2 x 10 ml of Streck; FFPE tumor tissue (optional)

MeSH Terms

Conditions

Neoplasms

Interventions

Hematologic Tests

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Haluk Tezcan, MD

  Lexent Bio

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Haluk Tezcan, MD

CONTACT

530-863-7922; htezcan@lexentbio.com

Ayse Z Tezcan, Ph.D.

CONTACT

530-863-7936; atezcan@lexentbio.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2014
• First Posted: November 11, 2014
• Study Start: December 1, 2014
• Primary Completion: November 1, 2019
• Study Completion: November 1, 2020
• Last Updated: August 14, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)