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Collection of Blood, Bone Marrow, Tumor or Tissue Samples

30. juni 2017 opdateret af: National Cancer Institute (NCI)

Acquisition of Blood, Bone Marrow, Tumor, or Tissue Samples

This study will collect biological samples-blood, bone marrow, tumor or other tissue samples-for use in cancer-related research. The specimens will be used for various tests of drug resistance, blood vessel formation, cancer-causing proteins and immune functions. The purpose is to identify steps in the cancer development process that may serve as targets for treatment and to test various therapies for current and future cancer treatment clinical trials.

Individuals 18 years of age and older with cancer or a pre-cancerous condition, such as colon polyps or cervical dysplasia, are eligible for this study, as are patients at high risk for cancer. In addition, patients who do not have cancer but require surgery, biopsy or other procedure for another medical reason may be included as normal specimen donors.

Participants will have about 40 milliliters (3 tablespoons) of blood drawn upon entering the study and additional 40-ml samples drawn periodically during the course of treatment. No more than 120 ml of blood will be drawn over a 12-month period. Some patients may require a surgical procedure or biopsy (removal of tumor tissue) for medical reasons or as part of their enrollment in a research treatment study. In such cases, a portion of the specimens collected during those procedures will be used for the research studies in this protocol.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

Patients will be evaluated at NNMC Clinics. Blood samples may be collected at the initial visit and at follow-up visits. Tumor samples may be obtained by fine needle aspirate, by removal of pleural or peritoneal fluid, or by excisional biopsy, or other procedure. In general, biopsy tissue will be obtained as an additional sample at the time of a medically indicated procedure. In some cases, a biopsy may be performed only to obtain a research sample providing the tumor is accessible with a minimal risk to the patient. Specific risks will be described in a separate consent to be obtained at the time of the biopsy. Tumor samples and blood samples will be processed and/or stored for use in research efforts in the laboratories of the Medical Oncology Branch, Experimental Transplant and Immunology Branch, or Genetics Branch, Center for Cancer Research, NCI at Navy and NIH.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

74

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Maryland
      • Bethesda, Maryland, Forenede Stater, 20892
        • National Institutes of Health Clinical Center, 9000 Rockville Pike
      • Bethesda, Maryland, Forenede Stater, 20889
        • National Naval Medical Center

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

  • INCLUSION CRITERIA:

Patients must have a performance status of ECOG greater than or equal to 3 for admission to this protocol.

Subjects must be at least 18 years old.

Patients with any malignancy, high-risk, pre-malignant condition (for example, colonic polyps, cervical dysplasia, atypical ductal hyperplasia or oral leukoplakia), undergoing reduction mammoplasty or prophylactic mastectomy are eligible.

Patients requiring a surgical procedure for any medical indication can be included on study. These patients would be considered normal donors (no diagnosis of cancer).

Patients requiring biopsy or any procedure for any medical indication can be included on study. These patients will be considered normal donors (no diagnosis of cancer).

Patients not requiring biopsy for a medical indication can be included on the study solely for the purpose of obtaining research samples, including blood, pleural fluid, or peritoneal fluid, or biopsy samples, providing the biopsy or aspiration procedure is of minimal risk, i.e., fine needle aspirate, bone marrow aspirate, or excisional biopsy.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

National Cancer Institute (NCI)

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

29. juli 2002

Studieafslutning

10. april 2012

Datoer for studieregistrering

Først indsendt

9. august 2002

Først indsendt, der opfyldte QC-kriterier

9. august 2002

Først opslået (Skøn)

12. august 2002

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

2. juli 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

30. juni 2017

Sidst verificeret

10. april 2012

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 020258
  • 02-C-0258

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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