Detection of Recurrent Colorectal Cancer by Assay of Novel Methylated DNA Markers in Plasma

Overview

Información sobre este estudio

The primary aims for this study:

  1. To select an optimal panel of novel MDMs for detection of recurrent or metastatic CRC and to assess MDM panel accuracy (sensitivity & specificity) for this application.

  2. To evaluate the ability of the plasma MDM assay to predict CRC recurrence when tested serially following curative resection of CRC metastases.

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.

CONTROLS

Inclusion Criteria:

  • Consent obtained.
  • Age ≥ 40 years in NOMAD study.
  • Normal colonoscopy within past 5 years.

Exclusion Criteria:

  • Known history of non-cutaneous (except for melanoma) cancer within prior 5 years (or new cancer emerging within 3 years following blood draw).
  • Inability to provide blood sample.

CASES

Inclusion Criteria:

  • Newly diagnosed or recurrent stage II-IV CRC seen on imaging and confirmed by histology (Note: Bloods may be drawn in patients with suspected recurrence on imaging and prior to histologic report, but final inclusion will require histological confirmation of recurrent tumor) OR patients with stage II-IV CRC on current systemic treatment (chemo or radiation therapy) here for imaging studies as routine treatment monitoring, OR patients currently with no evidence of disease (NED) from resected stage II CRC, resected stage III CRC, or stage IV CRC with complete surgical resection, and confirmed by imaging and histology.
  • Consent obtained and able to provide blood samples.
  • Age ≥ 18 years.

Exclusion Criteria:

  • Inability to provide blood sample.
  • Known history of non-cutaneous (except for melanoma) cancer outside of the colon within prior 3 years.

RETROSPECTIVE STUDY ON ARCHIVAL TUMOR SPECIMENS

CASES

Inclusion Criteria:

 

  • Consent recorded in record.
  • Age ≥ 18 years.

Exclusion Criteria:

  • History of radiation to site of tumor being studied
  • Known familial cancer syndrome (e.g. Lynch syndrome, familial adenomatous polyposis)

CONTROLS

  • Buffy coat specimens as negative controls.

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

Hao Xie, M.D., Ph.D.

Cerrado; inscripción por invitación

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El estudio no está abierto para todos los que cumplen con los criterios de elegibilidad, sino solamente para las personas que el equipo del estudio ha invitado a participar.

Contact information:

Hunter Miller

(507) 538-6747

Miller.Hunter@mayo.edu

Jacksonville, Fla.

Investigador principal de Mayo Clinic

Hao Xie, M.D., Ph.D.

Cerrado para la inscripción

More information

Publicaciones

Publications are currently not available
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CLS-20493012

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