- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00080639
CA-125 in Screening Patients at High Risk for Ovarian Cancer
Specialized Program Of Research Excellence (SPORE) In Ovarian Cancer/Cancer Genetics Network Collaborative Ovarian Cancer Screening Pilot Trial In High Risk Women
RATIONALE: Measuring levels of CA 125 in blood samples of women who have a high risk of developing ovarian cancer may help doctors detect cancer early and plan more effective treatment.
PURPOSE: This phase II trial is studying CA-125 levels in screening for cancer in women who are at high risk of developing ovarian cancer.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
OBJECTIVES:
Primary
- Determine the feasibility of prospective screening for ovarian cancer in high-risk patients.
- Determine normal ranges and distributions of CA 125 within and between these patients (with subclassification by menopausal status, estrogen replacement therapy usage, and prophylactic oophorectomy).
Secondary
- Determine estimates of the specificity and positive predictive value of a risk of cancer algorithm suitable for designing a definitive trial of screening for ovarian cancer in these patients.
OUTLINE: This is a multicenter, pilot study.
Patients undergo blood collection and CA 125 levels are measured at baseline and then every 3 months for 1-2 years. Patients may be referred for an ovarian ultrasound if indicated by the CA 125 results.
Patients are followed at 6 months and then annually thereafter.
PROJECTED ACCRUAL: A total of 2,400 patients will be accrued for this study within 1 year.
Studietyp
Kontakter och platser
Studieorter
-
-
Alabama
-
Birmingham, Alabama, Förenta staterna, 35294-3300
- Comprehensive Cancer Center at University of Alabama at Birmingham
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
DISEASE CHARACTERISTICS:
At high risk for developing ovarian cancer, as determined by meeting criteria for 1 of the following:
Family history of at least 2 ovarian or breast* cancers among the patient and first- and second-degree relatives within the same lineage**
- If breast cancer* is required to meet this criterion, at least 1 breast cancer* must be premenopausal (diagnosed at age 50 or under if menopausal status unknown) NOTE: **Multiple primary cancers in the same person satisfies this criterion
Ashkenazi Jewish ethnicity and meets criteria for 1 of the following:
- Prior breast cancer* diagnosis
One first-degree or 2 second-degree relatives with breast* or ovarian cancer
- If breast cancer is required to meet this criterion, at least 1 breast cancer* must be premenopausal (diagnosed at age 50 or under if menopausal status unknown)
Probability of BRCA1 or BRCA2 mutation greater than 20%, as determined by BRCAPRO 95% posterior probability interval
This criterion includes the following situations for which BRCAPRO is not required:
- Tested positive for a BRCA1 or BRCA2 mutation (100% probability)
- First- or second-degree relative with a BRCA1 or BRCA2 mutation NOTE: *Including ductal carcinoma in situ
- No ovarian cancer, including low malignant potential cancers or primary papillary serous carcinoma of the peritoneum
PATIENT CHARACTERISTICS:
Age
- 30 and over
Performance status
- Not specified
Life expectancy
- Not specified
Hematopoietic
- No hemophilia
- No other bleeding disorders
Hepatic
- Not specified
Renal
- Not specified
Pulmonary
- No emphysema
Other
- Not pregnant
- Negative pregnancy test
- Fertile patients must use effective contraception
- No psychiatric or psychological condition that would preclude giving informed consent
- No concurrent untreated malignancy except nonmelanoma skin cancer
- No other medical condition that would preclude blood draws (e.g., chronic infectious disease)
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- More than 3 months since prior adjuvant chemotherapy for cancer
Endocrine therapy
- Concurrent adjuvant hormonal therapy (e.g., tamoxifen, leuprolide, or goserelin) allowed
Radiotherapy
- More than 3 months since prior adjuvant radiotherapy for cancer
Surgery
- More than 3 months since prior intraperitoneal surgery (laparoscopy or laparotomy)
- Prior prophylactic oophorectomy allowed
Other
- More than 5 years since prior treatment (excluding hormonal therapy) for metastatic malignancy
- No concurrent participation in other ovarian cancer early detection trials
Studieplan
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: Kohort
- Tidsperspektiv: Blivande
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
---|---|
Determine the feasibility of prospective screening for ovarian cancer in high-risk patients.
Tidsram: baseline
|
baseline
|
Determine normal ranges and distributions of CA 125 within and between these patients (with subclassification by menopausal status, estrogen replacement therapy usage, and prophylactic oophorectomy).
Tidsram: baseline
|
baseline
|
Sekundära resultatmått
Resultatmått |
Tidsram |
---|---|
Determine estimates of the specificity and positive predictive value of a risk of cancer algorithm suitable for designing a definitive trial of screening for ovarian cancer in these patients.
Tidsram: baseline
|
baseline
|
Samarbetspartners och utredare
Samarbetspartners
Utredare
- Huvudutredare: Edward E. Partridge, MD, University of Alabama at Birmingham
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Neoplasmer efter histologisk typ
- Neoplasmer
- Urogenitala neoplasmer
- Neoplasmer efter plats
- Carcinom
- Neoplasmer, körtel och epitel
- Genitala neoplasmer, hona
- Sjukdomar i det endokrina systemet
- Ovariella sjukdomar
- Adnexala sjukdomar
- Gonadal sjukdomar
- Neoplasmer i endokrina körtel
- Ovariella neoplasmer
- Karcinom, äggstocksepitel
Andra studie-ID-nummer
- CDR0000353332
- UAB-120
- UAB-0120
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
produkt tillverkad i och exporterad från U.S.A.
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
Kliniska prövningar på Äggstockscancer
-
Ann & Robert H Lurie Children's Hospital of ChicagoOkändCystektomi | Godartade cystor Ovarian | Torsion | Maligna cystor OvarianFörenta staterna
-
Assistance Publique - Hôpitaux de ParisAktiv, inte rekryterandeOkomplicerad Tubo Ovarian AbscessFrankrike
-
Peking University Third HospitalHar inte rekryterat ännuOvarian clear cell carcinoma
-
Dansk FertilitetsklinikOkändKvinnlig infertilitet | Hypogonadism; OvarianDanmark
-
AstraZenecaAvslutadOvarian, Äggledaren, Peritoneal cancer, P53 MutationFörenta staterna, Kanada, Nederländerna
-
University Health Network, TorontoAvslutad
-
M.D. Anderson Cancer CenterGSK Pharma; LixteRekryteringOvarian clear cell carcinomaFörenta staterna
-
National University Hospital, SingaporeOkändOvarian clear cell carcinomaSingapore
-
Tongji HospitalWuhan University; Henan Cancer Hospital; Qilu Hospital of Shandong University och andra samarbetspartnersRekryteringOvarian clear cell carcinomaKina
-
SpringWorks Therapeutics, Inc.Aktiv, inte rekryterandeÄggstockscancer | Ovarian granulosa celltumör | Ovarian Granulosa-Stromal tumörFörenta staterna, Kanada, Polen
Kliniska prövningar på fysiologiska tester
-
Stanford UniversityHar inte rekryterat ännu
-
John SappNova Scotia Health Authority; Rochester Institute of TechnologyRekryteringHjärtinfarkt | Ventrikulär takykardiKanada
-
US Department of Veterans AffairsAvslutadIrritabel tarmsyndromFörenta staterna
-
M.D. Anderson Cancer CenterRekryteringBuken cancer | BäckencancerFörenta staterna
-
ReCode TherapeuticsSano Genetics; ReverbaRekryteringPrimär ciliär dyskinesiFörenta staterna
-
Washington University School of MedicineThe Foundation for Barnes-Jewish HospitalAvslutadLynch syndrom | Ärftlig bröst- och äggstockscancerFörenta staterna
-
St. Olavs HospitalNorwegian University of Science and TechnologyAvslutadTakykardi, Ventrikulär | Defibrillatorer, implanterbaraNorge
-
XDxOkändHjärtsjukdom | TransplantatavstötningFörenta staterna
-
International Centre for Diarrhoeal Disease Research...Columbia UniversityAvslutad
-
AgendiaRekryteringBröstcancerFörenta staterna, Israel, Grekland