A Study to Detect Cancers Through Elective Plasma-based CancerSEEK Testing

Overview

About this study

The purpose of this study is to obtain clinically characterized, whole blood specimens from participants with new or suspected diagnosis of (cancer subjects) and from participants who do not have a diagnosis of cancer (healthy subjects) to develop and refine assays for cancer in the blood

The primary objective of this study is to obtain clinically characterized, whole blood specimens from cancer and healthy subjects to develop and refine assays for cancer in the blood.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria - All Subjects:

≥ 50 years of age
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 or personal data to the study investigator.

Inclusion Criteria - Cancer Subjects Only:

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
Subject has suspicion of a primary malignancy of pancreatic, bladder, kidney/renal pelvis, testis or ovarian cancer based on imaging.

Exclusion Criteria:

Prior or concurrent cancer diagnosis defined as:
- Any previous cancer diagnosis within the past 5 years (with the exceptions of basal cell or squamous cell skin cancers); OR
- Recurrence of the same primary cancer within any timeframe; OR
- Concurrent diagnosis of multiple primary cancers.
Chemotherapy and/or radiation therapy within 5 years prior to enrollment/sample collection.
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.
Less than 3 days between fine needle aspiration (FNA) of target pathology and blood collection.
Less than 7 days between biopsy (other than FNA) of target pathology and blood collection.
IV contrast (e.g., CT and MRI) within 1 day [or 24 hours] of blood collection.
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.
Participant has an active febrile infection prior to blood draw.
History of an allogeneic bone marrow, stem cell transplant, or solid organ transplant.

Eligibility last updated 12/7/21. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location	Status
Rochester, Minn. Mayo Clinic principal investigator John Kisiel, M.D.	Closed for enrollment
Mankato, Minn. Mayo Clinic principal investigator Amrit Singh, M.B.B.S.	Closed for enrollment
La Crosse, Wis. Mayo Clinic principal investigator Scott Okuno, M.D.	Closed for enrollment
Eau Claire, Wis. Mayo Clinic principal investigator Eyad Al-Hattab, M.D.	Closed for enrollment
Scottsdale/Phoenix, Ariz. Mayo Clinic principal investigator Brenda Ernst, M.D.	Closed for enrollment
Albert Lea, Minn. Mayo Clinic principal investigator Mina Hanna, M.D.	Closed for enrollment

More information

Publications

Publications are currently not available

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