Detecting cancers Earlier Through Elective plasma-based CancerSEEK Testing

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 294

Inclusion Criteria

All subjects
1. >=50 years of age
2. Subject understands the study procedures and is able to provide informed
consent to participate in the study and authorization for release of relevant
protected health information to the study investigator.
Cancer Subjects Only
3. Subject has an untreated primary malignancy of breast, lung, colorectal,
prostate, bladder, uterine, kidney/renal pelvis, pancreatic, liver, stomach,
ovarian, esophageal cancer, head and neck squamous cell, thyroid, small
intestine, cervical, anal, vulva, or testis confirmed through pathology reports
and/or clinical/radiographic data.
Or
4. Subject has suspicion of a primary malignancy of pancreatic, bladder,
kidney/renal pelvis, testis or ovarian cancer based on imaging.

Exclusion Criteria

1. Prior or concurrent cancer diagnosis defined as:
a. Any previous cancer diagnosis within the past 5 years (with the exceptions
of basal cell or squamous cell skin cancers); OR
b. Recurrence of the same primary cancer within any timeframe; OR
c. Concurrent diagnosis of multiple primary cancers
2. Chemotherapy and/or radiation therapy within 5 years prior to
enrollment/sample collection.
3. Any treatment for the primary malignancy or sites of metastases. Subject may
not have started neo-adjuvant chemotherapy, neo-adjuvant radiation therapy,
immunotherapy or other treatment and/or surgery prior to blood sample
collection.
4. Less than 3 days between fine needle aspiration (FNA) of target pathology
and blood collection.
5. Less than 7 days between biopsy (other than FNA) of target pathology and
blood collection.
6. IV contrast (e.g., CT and MRI) within 1 day [or 24 hours] prior to blood
collection.
7. Individual has a condition the Investigator believes would interfere with
the subject*s ability to provide informed consent, comply with the study
protocol, which might confound the interpretation of the study results or put
the person at undue risk.
8. Participant has an active febrile infection prior to blood draw
9. History of an allogeneic bone marrow, stem cell transplant, or solid organ
transplant

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The purpose of this study is to obtain clinically characterized, whole blood<br /><br>specimens from cancer subjects and healthy subjects to develop and refine<br /><br>assays for cancer in the blood.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>N/A</p><br>

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