Pancreatic Cancer Early Detection Consortium
A legfontosabb adatok
- Ki végzi
- Arbor Research Collaborative for Health
- Hol
- Verona (Olaszország)A helyszín megnézéseMég 11 másik országban, 61 helyszínen
- Azonosító
- Állapot
- Toboroz
- Résztvevők
- 20 000 fő, tervezett
- Kezdés
- 2020. szept. 18.
- Várható befejezés
- 2030. dec. 31.
- A vizsgálat típusa
- Megfigyeléses, 10 csoport
- A regiszteradat frissítve
- 2026. október 29.
Ki vehet részt
MI-összefoglaló
A vizsgálat saját részvételi feltételeiből. Gép olvasta ki az oldalon álló regiszterszövegből, ezért tévedhet. Hogy ki vehet részt, azt a lenti regiszterszöveg és a vizsgálat csapata dönti el.
A vizsgálat olyan felnőtteket keres, akiknek a családjában előfordult hasnyálmirigyrák, akiknél hasnyálmirigyrák kockázatával összefüggő öröklött génelváltozás van, vagy hasnyálmirigy-cisztájuk van. Egyes csoportokba már hasnyálmirigyrákkal élők is bekerülhetnek.
- Életkor
- 18 és 90 év között. Egyes csoportokban legalább 35, 40 vagy 50 évesnek kell lenni.
- Nem
- Minden nem részt vehet.
- A betegség stádiuma
- A legtöbb csoport olyanoknak szól, akiknek nincs hasnyálmirigyrákjuk. Más csoportok hasnyálmirigyrákkal vagy a hasnyálmirigy magas fokú diszpláziájával élőknek szólnak, köztük újonnan diagnosztizált I. vagy II. stádiumú rákkal élőknek. Egy csoport hasnyálmirigy-cisztával élőknek szól.
- Biomarker vagy leletérték
- Egyes csoportokhoz kóroki vagy valószínűleg kóroki génelváltozás kell olyan génekben, mint a BRCA1, BRCA2, PALB2, ATM, CDKN2A, STK11 vagy PRSS1, vagy a Lynch-szindróma génjeiben: MLH1, MSH2, MSH6, PMS2 és EPCAM.
A részvétel fő kizáró okai
- Aki egyik csoport feltételeinek sem felel meg, nem csatlakozhat.
A regiszter feltételei, szó szerint
Mind a 18 feltétel megnézéseKevesebb
Ki vehet részt
- Individuals from the following groups who present for clinical evaluation and assessment of PDAC risk at any of the participating sites can be offered participation in the PRECEDE database:
- Cohort 1
- Individuals without history of PDAC meeting any of the following criteria:
- 2+ relatives with PDAC on same side of family where 2 affected are first degree related to each other and at least 1 affected is first degree related to subject; age 50+ or ≤10 years younger than earliest PDAC in family at time of diagnosis
- 2 affected first degree relatives with PDAC; age 50+ or 10 years younger than earliest PDAC in family
- BRCA1, BRCA2, PALB2, ATM, MLH1, MSH2, MSH6, PMS2, EPCAM pathogenic or likely pathogenic variant AND 1 first or second degree relative with PDAC; age 50+ or 10 years younger than earliest PDAC in family
- Familial Atypical Moles and Malignant Melanoma (FAMMM) with pathogenic or likely pathogenic CDKN2A variant; age 40+
- Peutz-Jegher syndrome with STK11 pathogenic or likely pathogenic variant; age 35+
- Hereditary pancreatitis with PRSS1 pathogenic or likely pathogenic variant and history of pancreatitis; age 40+; Cohort 2; Individuals without history of PDAC meeting any of the following criteria:
- ATM, BRCA1, BRCA2, or PALB2 pathogenic or likely pathogenic variant regardless of family history, age 50+
- 2+ relatives with PDAC on the same side of family, any degree of relation, not meeting other criteria above; age 50+ or 10 years younger than earliest PDAC in family
- 1 first degree relative with PDAC ≤ age 45; age up to 10 years younger than PDAC diagnosis in family member; Cohort 3 Individual meeting criteria for Cohorts 1 or 2 EXCEPT age (i.e. too young to qualify for Cohorts 1 or 2); Cohort 4 Individuals without history of PDAC presenting for evaluation who do not meet any criteria for 1-3, 6, or the Cyst Cohort; Cohort 5 Individuals without history of PDAC who are not otherwise engaged in pancreas surveillance at a participating site may be invited to participate in the PRECEDE database and to donate a biosample (e.g. blood, saliva, and/or buccal swab) for discovery studies. This may include relatives of individuals in Cohorts 1-4,6, and the Cyst Cohort; Cohort 6a; Individuals diagnosed with PDAC or pancreatic high-grade dysplasia after enrollment in PRECEDE meeting any of the following criteria:
- Family history includes at least one first degree relative with PDAC, or 2 relatives with PDAC who are first degree related to each other
- Personal or family history of a pathogenic or likely pathogenic germline variant in ATM, BRCA1, BRCA2, CDKN2A, EPCAM, MLH1, MSH2, MSH6, PALB2,PMS2, PRSS1, STK11; Cohort 6b; Individuals with a personal history of PDAC or pancreatic high-grade dysplasia meeting any of the following criteria:
- Family history includes at least one first degree relative with PDAC, or 2 relatives with PDAC who are first degree related to each other
- Personal or family history of a pathogenic or likely pathogenic germline variant in ATM, BRCA1, BRCA2, CDKN2A, EPCAM, MLH1, MSH2, MSH6, PALB2,PMS2, PRSS1, STK11
- Diagnosed ≤ age 45; Cohort 6c Individuals with newly diagnosed early stage (stage I or stage II) PDAC seen at a PRECEDE site that do not meet the criteria for 6a or 6b; Cohort 6d Individuals with PDAC seen at a PRECEDE site that do not meet the criteria for 6a, 6b, or 6c; Cyst Cohort Individuals with a personal history of a pancreatic cystic neoplasm not meeting any criteria for Cohorts 1-3 or 6 (no known family history of PDAC, no known pathogenic germline variants linked to PDAC risk)
Ki nem vehet részt
- Individuals not meeting the criteria above
Nézd meg, megfelelhetsz-e
Magadról válaszolj. Ez nem döntés: hogy részt vehetsz-e, azt csak a vizsgálat csapata mondhatja meg.
- 18 és 90 év között vagy?
Helyszínek itt: Olaszország
Még 11 másik országban, 61 helyszínen
- Azienda Ospedaliera Universitaria Integrata VeronaVerona, OlaszországContact: Salvatore PaiellaRésztvevőt keres
A vizsgálatról
Mit akar kideríteni a vizsgálat
The purpose of the Pancreatic Cancer Early Detection (PRECEDE) Consortium is to conduct research on multiple aspects of early detection and prevention of pancreatic ductal adenocarcinoma (PDAC) by establishing a multisite cohort of individuals with family history of PDAC and/or individuals carrying pathogenic/likely pathogenic germline variants (PGVs) in genes linked to PDAC risk for longitudinal follow up.
A vizsgálat 10 csoportja
- Cohort 1
Individuals without history of PDAC meeting any of the following criteria: 1. 2+ relatives with PDAC on same side of family where 2 affected are first degree related to each other and at least 1 affected is first degree related to subject; age 50+ or ≤10 years younger than earliest PDAC in family at time of diagnosis. 2. 2 affected first degree relatives with PDAC; age 50+ or 10 years younger than earliest PDAC in family 3. BRCA1, BRCA2, PALB2, ATM, MLH1, MSH2, MSH6, PMS2, EPCAM pathogenic or likely pathogenic variant AND 1 first or second degree relative with PDAC; age 50+ or 10 years younger than earliest PDAC in family 4. Familial Atypical Moles and Malignant Melanoma (FAMMM) with pathogenic or likely pathogenic CDKN2A variant; age 40+ 5. Peutz-Jegher syndrome with STK11 pathogenic or likely pathogenic variant; age 35+ 6. Hereditary pancreatitis with PRSS1 pathogenic or likely pathogenic variant and history of pancreatitis; age 40+
- Cohort 2
Individuals without history of PDAC meeting any of the following criteria: 1. ATM, BRCA1, BRCA2, or PALB2 pathogenic or likely pathogenic variant regardless of family history, age 50+ 2. 2+ relatives with PDAC on the same side of family, any degree of relation, not meeting other criteria above; age 50+ or 10 years younger than earliest PDAC in family 3. 1 FDR with PDAC ≤ age 45; age up to 10 years younger than PDAC diagnosis in family member
- Cohort 3
Individual meeting criteria for Cohorts 1 or 2 EXCEPT age (i.e. too young to qualify for Cohorts 1 or 2)
- Cohort 4
Individuals without history of PDAC presenting for evaluation who do not meet any criteria for 1-3, 6, or the Cyst Cohort.
- Cohort 5
Individuals without history of PDAC who are not otherwise engaged in pancreas surveillance at a participating site may be invited to participate in the PRECEDE database and to donate a biosample (e.g. blood, saliva, and/or buccal swab) for discovery studies. This may include relatives of individuals in Cohorts 1-4,6, and the Cyst Cohort.
- Cyst Cohort
Individuals with a personal history of a pancreatic cystic neoplasm not meeting any criteria for Cohorts 1-3 or 6 (no known family history of PDAC, no known pathogenic germline variants linked to PDAC risk)
- Cohort 6a
Individuals diagnosed with PDAC or pancreatic high-grade dysplasia after enrollment in PRECEDE meeting any of the following criteria: 1. Family history includes at least one first degree relative with PDAC, or 2 relatives with PDAC who are first degree related to each other 2. Personal or family history of a pathogenic or likely pathogenic germline variant in ATM, BRCA1, BRCA2, CDKN2A, EPCAM, MLH1, MSH2, MSH6, PALB2,PMS2, PRSS1, STK11
- Cohort 6b
Individuals with a personal history of PDAC or pancreatic high-grade dysplasia meeting any of the following criteria: 1. Family history includes at least one first degree relative with PDAC, or 2 relatives with PDAC who are first degree related to each other 2. Personal or family history of a pathogenic or likely pathogenic germline variant in ATM, BRCA1, BRCA2, CDKN2A, EPCAM, MLH1, MSH2, MSH6, PALB2,PMS2, PRSS1, STK11 3. Diagnosed ≤ age 45
- Cohort 6c
Individuals with newly diagnosed early stage (stage I or stage II) PDAC seen at a PRECEDE site that do not meet the criteria for 6a or 6b.
- Cohort 6d
Individuals with PDAC seen at a PRECEDE site that do not meet the criteria for 6a, 6b, or 6c.
Kérdések a vizsgálat csapatának
- Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
- Megtérítik az utazási költséget?
- Megtarthatom a saját orvosomat?
- Mi történik, ha ki akarok lépni?
Contact the study team: see the registry record → Contacts and Locations
Oldal nyomtatása az orvosomnakAdatok és források
- Regiszteradat
- Szerepel a ClinicalTrials.gov-on.
- MI-összefoglaló
- A vizsgálat saját részvételi feltételeiből. Gépi kiolvasás: 2026. november 12.
- Illeszkedési kérdések
- Forrás: NCT04970056: ki vehet részt
- A regiszteradat frissítve
- 2026. október 29.