Clinical trial NCT04213326: Detecting Cancers Earlier Through Elective Plasma-based CancerSEEK Testing
Official title: Detecting Cancers Earlier Through Elective Plasma-based CancerSEEK Testing - Ascertaining Serial Cancer Patients to Enable New Diagnostic
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Early Cancer Detection
Lead sponsor: Exact Sciences Corporation
Sponsor class: INDUSTRY
First posted: 2019-12-30
Enrollment: 6400
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 3000 total subjects 2000 healthy volunteers 1000 cancer volunteers

Brief summary: This is a prospective, observational study of 1,000 subjects with known or suspected cancer and 2,000 subjects with no known cancer.

Potential participants will be asked questions to confirm their eligibility by a nurse navigator, study staff member, or physician.

Informed consent will be carried out for eligible subjects in accordance with applicable federal regulations and International Council for Harmonisation (ICH)/Good Clinical Practice (GCP) guidelines.

Subjects will then complete a survey, and study staff will draw 60 mL of blood and measure the height and weight of the subject.

Where available, data from the medical records of the cancer subjects will reviewed and collected. In addition, non-cancer subjects will be requested to allow access to their medical records as an optional portion of their informed consent.

Detailed description: This is a prospective, observational study of 1,000 subjects with known or suspected cancer confirmed through pathology reports and/or clinical/radiographic data and 2,000 subjects with no known cancer. De-identified blood samples and clinical data will be collected from subjects to validate a classification algorithm for a new version of the CancerSEEK assay.

Potential participants will be asked questions to confirm their eligibility by a nurse navigator, study staff member, or physician to document screening including date of upcoming therapy or surgery for cancer patients if one has been scheduled, before providing informed consent to participate in the study. Study procedures outside of the pre-screening for eligibility will not be performed prior to the subject providing consent. Informed consent will be carried out in accordance with applicable federal regulations and International Council for Harmonisation (ICH)/Good Clinical Practice (GCP) guidelines. Prior to signing the informed consent form (ICF), potential participants will confirm that they understand the study and that they have no questions about the study.

The ICF may be offered by paper or electronically with the option to also review a paper copy provided by the nurse navigator or study coordinator either face-to-face on a tablet or via email. Potential participants will be given a phone number to call with any study specific questions. Copies of all signed consent forms will be stored centrally in a secure environment, and signed consent forms will thereby be available for verification by Thrive or its designee at any time.

Once the subject completes the survey, study staff will complete the blood draw and collect height and weight data. For some participants, their contact information and unique study identifier (ID) will be sent securely to a third-party vendor who will contact the subject within 24 hours to schedule the blood draw and height and weight measurements at a location convenient to the subject.

For all subjects, study staff and the third-party vendor performing the blood collection will verify the following before performing the blood draw and height and weight measurements: participant identity and age against a form of identification, that consent to participate has been given, that the participants in the cancer arm are still treatment naïve, and that they do not have a fever that could be caused by an infection. The blood collection vendor will ensure all required data are captured and included with the blood sample, that the sample is collected and packaged according to laboratory manual specifications, and that the sample is shipped to the indicated processing lab with the required expediency. Following all study visits, study staff and third party vendor staff will complete a visit checklist confirming all of the study activities that occurred.

Subjects in the Cancer cohort will be identified via nurse navigation, study staff or oncology physicians in local offices. The nurse navigator or study staff will verify eligibility through chart review and pre-screen, approach the subject about the study opportunity, and present the informed consent form. For participants enrolling electronically, participants will be presented with a secured tablet device on which the subject will watch a brief video about the study, read the informed consent and provide electronic consent. Some participants may also have the option of having the video, informed consent and survey emailed to them. Upon consent and enrollment, subjects will be assigned a unique subject study ID, which will be used to track the subject, their data and their biospecimen throughout study operations. Consented subjects will then be directed to complete a survey via the tablet device, email or paper. Participants will be allowed to skip questions in the survey or select the answer option "prefer not to answer." Subject data will be tracked in real-time by central study staff to ensure desired tumor type diversification and communicate enrollment strategy changes to the nurse navigators and study staff.

Eligibility criteria: Inclusion Criteria:

* Age 50 or greater
* Ability to understand the nature of this study and give written informed consent

CANCER COHORT:

Either of the following:

* Histologic diagnosis of cancer with no prior systemic or definitive therapy (any stage, including, inclusive of is-situ carcinoma)

Or

* Subject with high suspicion of cancer through radiological and/or clinical assessment who are scheduled for resection or biopsy within 6 weeks of study blood collection and have not received prior systemic or definitive therapy.

NON-CANCER COHORT

* No prior history of cancer

Exclusion Criteria:

ALL PATIENTS

* Evidence of active febrile infection prior to blood draw.
* Women who are pregnant or breast-feeding.
* History of an allogeneic bone marrow, stem cell transplant, or solid organ transplant.
* Judgment by the Investigator or study staff of any other reason that would prohibit the inclusion of the subject in the study.

CANCER COHORT

* Subjects newly diagnosed with a hematologic malignancy, primary central nervous system tumor, prostate cancer, or skin cancer (including melanoma).
* History of, or currently receiving, systemic or definitive cancer treatment including curative surgical resection, chemotherapy, radiation therapy, immunotherapy, and hormone therapy.

NON-CANCER COHORT

• None

Primary outcomes:
measure: Study Data and Samples Were Used for CancerSEEK Assay Development
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Thousand Oaks
country: United States
facility: Sarah Cannon
state: California
city: Denver
country: United States
facility: Sarah Cannon
state: Colorado
city: Fort Walton Beach
country: United States
facility: Sarah Cannon
state: Florida
city: Ocala
country: United States
facility: Sarah Cannon
state: Florida
city: Pensacola
country: United States
facility: Sarah Cannon
state: Florida
city: Augusta
country: United States
facility: Sarah Cannon
state: Georgia
city: Macon
country: United States
facility: Sarah Cannon
state: Georgia
city: Savannah
country: United States
facility: Sarah Cannon
state: Georgia
city: Kansas City
country: United States
facility: Sarah Cannon
state: Kansas
city: Overland Park
country: United States
facility: Sarah Cannon
state: Kansas
city: Independence
country: United States
facility: Sarah Cannon
state: Missouri
city: Las Vegas
country: United States
facility: Sarah Cannon
state: Nevada
city: Nashville
country: United States
facility: Sarah Cannon
state: Tennessee
city: Richmond
country: United States
facility: Sarah Cannon
state: Virginia
Study officials:
affiliation: Sarah Cannon
name: Dax Kurbegov, MD
role: PRINCIPAL_INVESTIGATOR
References: