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

Overview

Información sobre este estudio

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.

 

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

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.

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus Contacto

Rochester, Minn.

Investigador principal de Mayo Clinic

John Kisiel, M.D.

Cerrado para la inscripción

Contact information:

Kari Lowrie

(507) 293-3702

Lowrie.Kari@mayo.edu

Mankato, Minn.

Investigador principal de Mayo Clinic

Amrit Singh, M.B.B.S.

Cerrado para la inscripción

Contact information:

Danielle Mutschler R.N.

(507) 594-6895

Mutschler.Danielle@mayo.edu

La Crosse, Wis.

Investigador principal de Mayo Clinic

Scott Okuno, M.D.

Cerrado para la inscripción

Contact information:

Moua Torgerson

(608) 392-9142

torgerson.moua@mayo.edu

Eau Claire, Wis.

Investigador principal de Mayo Clinic

Eyad Al-Hattab, M.D.

Cerrado para la inscripción

Contact information:

Linh Tran CCRP

(715) 838-5871

Tran.Linh@mayo.edu

Albert Lea, Minn.

Investigador principal de Mayo Clinic

Mina Hanna, M.D.

Abierto para la inscripción

Contact information:

Danielle Mutschler R.N.

(507) 377-4817

Mutschler.Danielle@mayo.edu

Scottsdale/Phoenix, Ariz.

Investigador principal de Mayo Clinic

Brenda Ernst, M.D.

Abierto para la inscripción

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publicaciones

Publications are currently not available
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CLS-20521969

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