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
|Condition or disease|
|Neoplasms, Non-hematologic - Stage I-III|
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|
|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|
Early stage neoplasm
Patients with stage I-III early stage non-hematologic neoplasm
Patients undergoing surgery for a non-malignant condition with no prior history of malignancy.
- 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.
- 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
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
|Contact: Haluk Tezcan, MDfirstname.lastname@example.org|
|Contact: John Spinosa, MDemail@example.com|
|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|
|Principal Investigator:||Haluk Tezcan, MD||Lexent Bio|