- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT00526578
Pancreatic Cancer Genetic Epidemiology (PACGENE) Study
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
Participants in this study will be part of a pancreatic cancer genetic epidemiology consortium (herein referred to as "PACGENE"), which includes researchers at these institutions: Mayo Clinic; Johns Hopkins University; Creighton University; University of Toronto Mount Sinai Hospital; Dana Farber; and Karmanos Cancer Institute. Participants have either been diagnosed with pancreatic cancer or are family members of pancreatic cancer patients.
Participants will be asked questions by a trained interviewer using an approved questionnaire. The topics will include demographic data (age, race, etc.), exposures, medical history data, family history of cancer and other conditions, and other lifestyle factors. It should take about 30-40 minutes to complete the questionnaire.
Participants in this study will also have about one and a half tablespoons of blood drawn. Blood that is collected will only be used by researchers involved in this study. If obtaining a blood sample is not possible, the study staff will ask for a saliva sample using an ORAGENE kit. Neither participants nor their physicians will receive individual reports of this research. Results will not be placed in the participant's health records. All information will be kept confidential and used only for this research.
There is a rare chance that a research team member could be accidentally exposed to your blood or body fluids. If that occurs, extra blood (about 2 teaspoons) may be drawn to test for infections such as hepatitis and HIV (the AIDS virus). An existing blood sample may be used for these tests instead. You will be told that your blood is being tested and the results of your test. Researchers will ask how you would like to receive the results, such as by phone or certified letter. The test results and your name, address, date of birth, and sex will be recorded in the confidential M. D. Anderson medical records.
If you test positive for hepatitis or HIV, the test results and your name, address, date of birth, and sex will be shared with appropriate health authorities as required by law. You will also be given a list of places in your area so that you can receive further testing and treatment.
For the protection of your privacy, the study staff has obtained a Certificate of Confidentiality from the National Institutes of Health. With this certificate, the researchers cannot be forced to disclose information that may identify you, even by a court subpoena, in any federal, state, or local civil, criminal, administrative, legislative, or other proceedings. The researchers will use the certificate to resist any demands for information that would identify you, except as explained below.
The certificate cannot be used to resist a demand for information from personnel of the United State Government that is used for auditing or evaluation of Federally funded projects or for information that must be disclosed in order to meet the requirements of the federal Food and Drug Administration (FDA).
You should understand that a Certificate of Confidentiality does not prevent you or a member of your family from voluntarily releasing information about yourself or your involvement in this research. If an insurer, employer, or other person obtains your written consent to receive research information, then the researchers may not use the certificate to withhold that information.
This is an investigational study. This study will include a total of 1,000 participants recruited at M. D. Anderson.
Typ studie
Zápis (Očekávaný)
Kontakty a umístění
Studijní místa
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Texas
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Houston, Texas, Spojené státy, 77030
- University of Texas MD Anderson Cancer Center
-
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
Popis
Inclusion Criteria:
1) An effected or uneffected member of a family, age 18 or older, that has two or more reported pancreatic cancers in the family.
Exclusion Criteria:
- Cases under age 18.
- Relatives of pancreatic cancer cases under age 18.
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
|---|---|
|
Questionnaire
Pancreatic cancer patients or family member.
|
Questionnaire taking about 30-40 minutes to complete.
Ostatní jména:
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Identification of susceptibility genes in high risk familial pancreatic cancer (FPC) pedigrees using cutting-edge genetic analysis methods
Časové okno: 8 Years
|
Data collection from patient response to 30-40 minute questionnaire and blood test.
|
8 Years
|
Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Carrie Daniel-MacDougall, PHD, M.D. Anderson Cancer Center
Publikace a užitečné odkazy
Užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Očekávaný)
Dokončení studie (Očekávaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- ID02-139
- 1R01CA097075-01 (Grant/smlouva NIH USA)
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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