Detection of Tumor DNA in Blood Samples From Cancer Patients

NCT ID: NCT02288754

Last Updated: 2019-08-14

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

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Recruitment Status

UNKNOWN

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-12-31

Study Completion Date

2020-11-30

Brief Summary

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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

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Conditions

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Cancer Tumors

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Stage II or III curative surgery (closed to accrual)

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

Blood test

Intervention Type DIAGNOSTIC_TEST

No intervention except to collect blood for diagnostic test development

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.

Blood test

Intervention Type DIAGNOSTIC_TEST

No intervention except to collect blood for diagnostic test development

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.

Blood test

Intervention Type DIAGNOSTIC_TEST

No intervention except to collect blood for diagnostic test development

Interventions

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Blood test

No intervention except to collect blood for diagnostic test development

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Lexent Bio, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Haluk Tezcan, MD

Role: PRINCIPAL_INVESTIGATOR

Lexent Bio

Locations

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Cancer Care Associates

Torrance, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Haluk Tezcan, MD

Role: CONTACT

530-863-7922

Ayse Z Tezcan, Ph.D.

Role: CONTACT

530-863-7936

Facility Contacts

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David Chan, MD

Role: primary

310-750-3300

Other Identifiers

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LB1985106

Identifier Type: -

Identifier Source: org_study_id

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