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Detection of Tumor DNA in Blood Samples From Patients With Early Stage Cancer and "Healthy Controls"

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ClinicalTrials.gov Identifier: NCT03071809
Recruitment Status : Recruiting
First Posted : March 7, 2017
Last Update Posted : September 27, 2017
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-derived nucleic acids in the blood of patients diagnosed with an early stage solid tumor who are either commencing, currently undergoing or have completed treatment. This approach will allow the investigators 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
Neoplasms, Non-hematologic - Stage I-III

Detailed Description:

The aim of this study is to employ genomic detection methodologies to measure the relative amount of tumor-derived nucleic acids in the blood of patients diagnosed with an early stage solid tumor who are either commencing, currently undergoing or have completed treatment. This approach will allow the investigators to develop a quantitative measure of therapy efficacy via the counting of the relative changes in tumor molecules over the course of treatment.

The presence of circulating tumor-derived cfDNA in the plasma of patients can potentially enable a non-invasive means of detecting the presence or absence of tumor, assessing tumor burden and characterizing tumor biology in patients with cancer. The ability to measure the distribution of circulating tumor DNA may allow determination of a quantitative tumor load score in plasma that correlates to clinical tumor load. Clinical tumor load is a measure of disease burden, and the investigators propose to test in this study whether the tumor load score can measure this disease burden. A simple, reliable measure of disease burden would have diverse utility during patient therapy.


Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Detection of Tumor DNA in Blood Samples From Patients With Early Stage Cancer and "Healthy Controls"
Actual Study Start Date : June 30, 2017
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : April 2022

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort
Early stage neoplasm
Patients with stage I-III early stage non-hematologic neoplasm
Healthy Control
Patients undergoing surgery for a non-malignant condition with no prior history of malignancy.



Primary Outcome Measures :
  1. Detection of signal in the presence of active neoplasm [ Time Frame: 2 years ]
    To determine the association between the tumor load score and clinical tumor load as assessed with the current standard of care methods and pathology findings.

  2. Determine change in signal after surgery [ Time Frame: 5 years ]
    To determine the response of tumor load score as a function of tumor presence as determined pre- and post-surgery intended to be curative


Biospecimen Retention:   Samples With DNA
Whole Blood FFPE (optional)


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Up to 200 patients from multiple clinical sites will be enrolled in this study. Patients are eligible for this study if they are diagnosed with a solid tumor and undergoing curative resection. In addition, up to 200 participants with no prior or current diagnosis of cancer will be enrolled as a control group, i.e. "healthy control," for assay development.
Criteria

Inclusion Criteria:

1. For all participants:

  • Age 18 years or older
  • Able to understand and grant informed consent
  • Able to have their blood drawn at enrollment before surgery and 7 to 28 days after surgery

For participants with early stage solid tumors:

  • Diagnosed with an early stage (I-III) solid tumor with curative intent surgery without neoadjuvant therapy planned

For "healthy control" subgroup:

  • No prior or current diagnosis of any cancer. Participants with prior in situ cancer or non-melanoma skin cancer will be allowed to participate but will not be included in the "healthy control" cohort and will be analyzed separately.

Exclusion Criteria:

  • Unable to grant informed consent or comply with all study procedures
  • Diagnosed with a hematological malignancy (acute or chronic leukemia, myelodysplastic syndrome, myeloproliferative neoplasm, myeloma or lymphoma).

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): NCT03071809


Contacts
Contact: Haluk Tezcan, MD 5308637922 htezcan@lexentbio.com
Contact: John Spinosa, MD 6198389833 jspinosa@lexentbio.com

Locations
United States, California
La Jolla Surgery Recruiting
La Jolla, California, United States, 92121
Contact: Mark Sherman, MD    530-863-7922      
Principal Investigator: Mark Sherman, MD         
Sponsors and Collaborators
Lexent Bio, Inc.
Investigators
Principal Investigator: Haluk Tezcan, MD Lexent Bio

Responsible Party: Lexent Bio, Inc.
ClinicalTrials.gov Identifier: NCT03071809     History of Changes
Other Study ID Numbers: LB-2017-03-01
First Posted: March 7, 2017    Key Record Dates
Last Update Posted: September 27, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Keywords provided by Lexent Bio, Inc.:
Solid tumor
carcinoma
sarcoma
stage I
stage II
stage III