- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00898482
Collecting and Storing Samples of Blood From Patients With Pancreatic Cancer and Healthy Participants
Pancreatic Cancer Serum and Peripheral Blood Lymphocyte Repository
RATIONALE: Collecting and storing samples of blood from patients with cancer and healthy participants to test in the laboratory may help the study of cancer in the future.
PURPOSE: This study is collecting and storing samples of blood from patients with pancreatic cancer and healthy participants.
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
OBJECTIVES:
- Establish a central pancreatic cancer specimen (including serum and peripheral blood lymphocytes) repository to serve as a resource for current or future scientific studies.
- Utilize the clinical database to perform clinicopathologic correlation with the results of those studies.
- Test new hypotheses as they emerge.
OUTLINE: This is a prospective study.
Blood is collected from patients with pancreatic cancer at baseline and then every 3-6 months for up to 2 years. All other participants have blood collected at baseline and complete questionnaires at baseline and then every 3-6 months for up to 2 years. Serum and peripheral blood lymphocytes obtained from the blood samples are frozen and stored.
PROJECTED ACCRUAL: A total of 200 patients and 200 other participants will be accrued for this study.
Undersøgelsestype
Tilmelding (Faktiske)
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
DISEASE CHARACTERISTICS:
Meets 1 of the following criteria:
- Histologically confirmed pancreatic malignant neoplasm
- Serologically or image-confirmed diagnosis of pancreatitis or nonmalignant pancreatic disease
Healthy, at-risk participant meeting the following criteria:
- Smoker, diabetic, and/or has a family history of pancreatic cancer
- Healthy participant (no history of cancer)
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- Not specified
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: Kun etui
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
Sunde individer
|
This is a non-intervention study.
Non-intervention study.
|
|
At risk individuals
|
This is a non-intervention study.
Non-intervention study.
|
|
Cancer patients
|
This is a non-intervention study.
Non-intervention study.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Establishment of a central pancreatic cancer specimen repository
Tidsramme: No time frame
|
No time frame
|
|
Utilization of the clinical database to perform clinicopathologic correlation with the results of current or future scientific studies
Tidsramme: No time frame
|
No time frame
|
|
Test new hypotheses as they emerge
Tidsramme: No time frame
|
No time frame
|
Samarbejdspartnere og efterforskere
Samarbejdspartnere
Efterforskere
- Studiestol: Daniel A. Laheru, MD, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- JHOC-J0533 CDR0000452792
- P30CA006973 (U.S. NIH-bevilling/kontrakt)
- JHOC-J0533
- JHOC-05042601
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