Collection of Blood From Patients With Cancer

Biospecimen Acquisition From Human Subjects

Patrocinadores

Patrocinador principal: National Cancer Institute (NCI)

Fuente National Institutes of Health Clinical Center (CC)
Resumen breve

This study will collect blood from patients with cancer to study the level of cells which decrease the immune response (suppressor cells) before and after chemotherapy. Patients 18 years of age and older with cancer may participate. This study does not involve treatment.

Participants will have about 50 ml (3 tablespoonfuls) of blood drawn. Depending on their condition, patients may be invited to enroll in a clinical research study involving chemotherapy, radiotherapy, or surgery. Additional 40-ml blood samples may be drawn during the course of treatment.

Descripción detallada

Background:

- Correlative studies performed on biospecimens of human subjects can be used to investigate the biology of solid tumors, inform the development of new strategies for treating those cancers, and evaluate these new therapeutic approaches. Specific areas of interest include, but are not limited to:

- the underlying mechanisms of tumor-specific immune response and suppression in cancer patients

- genetic and molecular profiling of tumors through circulating tumor cell (cTC), circulating DNA, and tissue analysis

- investigation of potential early diagnostic and prognostic indicators for solid tumors such as cTCs and miRNA expression of serum exosomes

- identification of mechanisms of drug-related adverse events and correlation with clinical parameters

- the role of commensal gut microbiota in both the innate and adaptive responses to tumors as well as with the use of anticancer agents

Objectives:

- Analyze biospecimens such as tissue, urine, saliva, stool and blood components, which include serum, leukocytes, peripheral blood mononuclear cells (PBMC), and circulating tumor cells (cTC), of human subjects.

- Correlate analysis results with clinical parameters such as demographics, toxicities, and treatment outcomes.

- Undertake genetic analysis of both prokaryotic and eukaryotic samples for advanced mutational analysis.

Eligibility:

- Patients and healthy volunteers whose biospecimens are of interest to NIH investigators.

- 18 years of age or older.

Design:

- Subject cases will be evaluated by NCI or Interventional Radiology, NIH Clinical Center personnel. Blood, tissue, urine, saliva or other samples may be collected at the initial visit and at follow-up visits.

Estado general Recruiting
Fecha de inicio July 16, 2002
Tipo de estudio Observational
Resultado primario
Medida Periodo de tiempo
Collection of tissue, urine, saliva, stool and blood components, which include serum, leukocytes, peripheral blood mononuclear cells (PBMC), and circulating tumor cells (cTC), of human subjects. Ongoing
Correlate analysis results with clinical parameters such as demographics, toxicities, and treatment outcomes. Ongoing
Undertake genetic analysis of both prokaryotic and eukaryoticsamples for advanced mutational analysis. Ongoing
Inscripción 1500
Condición
Elegibilidad

Método de muestreo: Non-Probability Sample

Criterios:

- INCLUSION CRITERIA:

Patients 18 years of age and older are eligible.

Patients must have a performance status of ECOG 0, 1, 2, or 3 for admission to this protocol.

INCLUSION FOR APHERESIS:

Effective with Amendment CC, patients will no longer be asked to undergo apheresis. This content is being retained for historical reference.

Hemoglobin greater than or equal to 10 mg/dL and platelet count > 75,000/mm(3)

Weight greater than 25 kg

HIV negative

Prothrombin Time within normal limits

Partial Thromboplastin Time within normal limits

Medically indicated central line in place or adequate peripheral venous access

EXCLUSION CRITERIA:

Children will not be eligible.

Género: All

Edad mínima: 18 Years

Edad máxima: 100 Years

Voluntarios Saludables: Accepts Healthy Volunteers

Oficial general
Apellido Papel Afiliación
Jennifer L Marte, M.D. Principal Investigator National Cancer Institute (NCI)
Contacto general

Apellido: Sheri A McMahon, R.N.

Teléfono: (240) 760-7968

Email: [email protected]

Ubicación
Instalaciones: Estado: Contacto: National Institutes of Health Clinical Center, 9000 Rockville Pike For more information at the NIH Clinical Center contact National Cancer Institute Referral Office (888) NCI-1937
Ubicacion Paises

United States

Fecha de verificación

January 14, 2020

Fiesta responsable

Tipo: Sponsor

Palabras clave
Tiene acceso ampliado No
Condición Examinar
Grupo de brazo

Etiqueta: Healthy Volunteers

Descripción: Healthy volunteers 18 years of age and older

Etiqueta: Patients

Descripción: Patients with cancer 18 years of age and older

Información de diseño del estudio

Modelo de observación: Cohort

Perspectiva de tiempo: Prospective

Fuente: ClinicalTrials.gov