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Detection of Tumor DNA in Blood Samples From Cancer Patients

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ClinicalTrials.gov Identifier: NCT02288754
Recruitment Status : Recruiting
First Posted : November 11, 2014
Last Update Posted : August 8, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Cancer Tumors Diagnostic Test: Blood test

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Detection of Tumor DNA in Blood Samples From Patients With Late Stage Cancer and "Healthy Controls"
Study Start Date : December 2014
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : November 2020

Group/Cohort Intervention/treatment
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
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.
Diagnostic Test: Blood 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.
Diagnostic Test: Blood test
No intervention except to collect blood for diagnostic test development




Primary Outcome Measures :
  1. Correlation between the tumor load score and patient response to therapies. [ Time Frame: 5 years ]
    Determination of a direct correlation between the tumor load score and patient response to therapies.


Secondary Outcome Measures :
  1. Determination of particular mutation events which underlie the basis of any established correlation with therapy response. [ Time Frame: 5 years ]
    To determine which particular mutation events underlie the basis of any established correlation with therapy response.


Biospecimen Retention:   Samples With DNA
Blood 2 x 10 ml of Streck FFPE tumor tissue (optional)


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02288754


Contacts
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Contact: Haluk Tezcan, MD 530-863-7922 htezcan@lexentbio.com
Contact: Ayse Z Tezcan, Ph.D. 53-863-7936 atezcan@lexentbio.com

Locations
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United States, California
James Sinclair, MD Recruiting
La Jolla, California, United States, 92037
Contact: Judith Sheard, MPH    858-342-4439      
Sharp Clinical Oncology Research Completed
San Diego, California, United States, 92123
Cancer Care Associates Recruiting
Torrance, California, United States, 90277
Contact: David Chan, MD    310-750-3300      
United States, Idaho
Summit Cancer Center Recruiting
Post Falls, Idaho, United States, 83854
Contact: Brian Samuels, MD    208-618-5212      
Contact: Jalene Tangen    (208) 618-5212      
Sponsors and Collaborators
Lexent Bio, Inc.
Investigators
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Principal Investigator: Haluk Tezcan, MD Lexent Bio

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Responsible Party: Lexent Bio, Inc.
ClinicalTrials.gov Identifier: NCT02288754     History of Changes
Other Study ID Numbers: LB1985106
First Posted: November 11, 2014    Key Record Dates
Last Update Posted: August 8, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Lexent Bio, Inc.:
DNA in Tumors
cfDNA
WGS
Advanced stage cancer
Solid tumors