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

NCT03071809 | Terminated

• 1 other identifier: LB-2017-03-01
• Study Type: observational
• Target: 5
• 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-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.

Conditions

Neoplasms, Non-hematologic - Stage I-III

Keywords

Solid tumor; carcinoma; sarcoma; stage I; stage II; stage III

Outcome Measures

Primary Outcomes (2)

• Detection of signal in the presence of active neoplasm

  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 years

• Determine change in signal after surgery

  To determine the response of tumor load score as a function of tumor presence as determined pre- and post-surgery intended to be curative

  5 years

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• \. 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Lexent Bio, Inc.: lead

Study Sites (1)

Alisa Williams, MD Inc

San Diego, California, 92103, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole Blood; FFPE (optional)

MeSH Terms

Conditions

Neoplasms; Carcinoma; Sarcoma

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Connective and Soft Tissue

Study Officials

• Haluk Tezcan, MD

  Lexent Bio

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: March 1, 2017
• First Posted: March 7, 2017
• Study Start: June 30, 2017
• Primary Completion: March 15, 2019
• Study Completion: March 15, 2019
• Last Updated: August 14, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)