Specimen and Data Study for Ovarian Cancer Early Detection and Prevention

StatusRecruiting
PhaseNot specified
Started

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Record History

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  1. Re-verified, no change to tracked fieldsv39
  2. Primary completion date: Dec 2020 to Dec 2030v38 Show 5 more changesShow less
    • Primary endpoint revised
    • Study completion date: Dec 2040
    • Interventions: laboratory biomarker analysis (Other), screening questionnaire administration (Other), study of high risk factors (Procedure) to Ca-125 (Other), Surgery (Procedure), screening questionnaire administration (Other)
    • Secondary endpoints revised (2)
    • Study arms: 1 to 3
  3. 6 versions Re-verified since May 14, 2013, no change to tracked fieldsv32-v37
  4. Eligibility criteria expanded, about 36 words
    • Study description expanded, about 9 words
    • Study title expanded, about 5 words
    v31
  5. Phase: Not applicable to Not specifiedv30 Show 7 more changesShow less
    • Lead sponsor: Robert H. Lurie Cancer Center to Northwestern University
    • Primary endpoints: 3 to 1
    • Primary completion date: Dec 2020
    • Interventions: evaluation of cancer risk factors (Procedure), laboratory biomarker analysis (Other), screening questionnaire administration (Other), study… to laboratory biomarker analysis (Other), screening questionnaire administration (Other), study of high risk factors (Procedure)
    • Eligibility criteria shortened, about 38 words
    • Secondary endpoints expanded, about 32 words
    • Study arms: 0 to 1
Show 28 earlier versionsHide 28 earlier versions
  1. Interventions: chromosomal translocation analysis (Genetic), comparative genomic hybridization (Genetic), cytology specimen collection procedure (Other)… to evaluation of cancer risk factors (Procedure), laboratory biomarker analysis (Other), screening questionnaire administration (Other), study…
    • Eligibility criteria expanded, about 23 words
    • Study description shortened, about 142 words
    • Study title shortened, about 1 word
    v29
  2. Site contact updatedv28
  3. Re-verified, no change to tracked fieldsv27
  4. Interventions: chromosomal translocation analysis (Procedure), comparative genomic hybridization (Procedure), cytology specimen collection procedure… to chromosomal translocation analysis (Genetic), comparative genomic hybridization (Genetic), cytology specimen collection procedure (Other)…v26
  5. 2 versions Re-verified since Jul 23, 2008, no change to tracked fieldsv24-v25
  6. Interventions: chromosomal translocation analysis (Procedure), comparative genomic hybridization (Procedure), cytology specimen collection procedure… to chromosomal translocation analysis (Procedure), comparative genomic hybridization (Procedure), cytology specimen collection procedure…v23
  7. Re-verified, no change to tracked fieldsv22
  8. Phase: Not specified to Not applicablev21
  9. Start date: Mar 2000v20
  10. Interventions: chromosomal translocation (Procedure), comparative genomic analysis (Procedure), cytology specimen collection procedure (Procedure)… to chromosomal translocation analysis (Procedure), comparative genomic hybridization (Procedure), cytology specimen collection procedure…v19
  11. Interventions: chromosomal translocation (Procedure), comparative genomic analysis (Procedure), cytology specimen collection procedure (Procedure)… to chromosomal translocation (Procedure), comparative genomic analysis (Procedure), cytology specimen collection procedure (Procedure)…v18
  12. Interventions: Intervention/procedure (Procedure), chromosomal translocation (Procedure), comparative genomic analysis (Procedure), cytologic technique… to chromosomal translocation (Procedure), comparative genomic analysis (Procedure), cytology specimen collection procedure (Procedure)…v17
  13. Interventions: Intervention/procedure (Procedure), biological markers (Procedure), chromosomal translocation (Procedure), comparative genomic analysis… to Intervention/procedure (Procedure), chromosomal translocation (Procedure), comparative genomic analysis (Procedure), cytologic technique…v16
  14. Interventions: biological markers (Procedure), chromosomal translocation (Procedure), comparative genomic analysis (Procedure), cytologic sampling… to Intervention/procedure (Procedure), biological markers (Procedure), chromosomal translocation (Procedure), comparative genomic analysis…v15
  15. Interventions: biological markers (Procedure), chromosomal translocation (Procedure), comparative genomic analysis (Procedure), cytogenetic analysis… to biological markers (Procedure), chromosomal translocation (Procedure), comparative genomic analysis (Procedure), cytologic sampling…
    • Study title shortened, about 2 words
    v14
  16. 2 versions Re-verified since Mar 5, 2007, no change to tracked fieldsv12-v13
  17. Study Status, Eligibilityv11
  18. 3 versions Re-verified since Jan 5, 2007, no change to tracked fieldsv8-v10
  19. Enrollment target: 6000v7
  20. Re-verified, no change to tracked fieldsv6
  21. Interventions: biological markers (Procedure), chromosomal translocation (Procedure), comparative genomic analysis (Procedure), cytogenetic analysis… to biological markers (Procedure), chromosomal translocation (Procedure), comparative genomic analysis (Procedure), cytogenetic analysis…v5
  22. Re-verified, no change to tracked fieldsv4
  23. Study title shortened, about 1 wordv3
  24. Re-verified, no change to tracked fieldsv2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Northwestern University
389 trials monitored
See 35 trials at risk
Ovarian Cancer
1,347 trials monitored
See 95 trials at risk
Sarcoma
1,030 trials monitored
See 72 trials at risk
Cervical Cancer
922 trials monitored
See 50 trials at risk
and 1 more disease
RATIONALE: To improve strategies for detection and prevention of early-stage disease. PURPOSE: This research study is collecting specimens and data to develop better methods for early detection and prevention of ovarian cancer among the high risk population and those who have the disease.
Trial Details
NCT Number NCT00005095
Lead Sponsor Northwestern University
Collaborators: National Cancer Institute (NCI)
Conditions
(from sponsor)		 Cervical Cancer, Endometrial Cancer, Fallopian Tube Cancer, Hereditary Breast/Ovarian Cancer (brca1, brca2), Ovarian Cancer, Sarcoma, Uterine Leiomyomata, Vaginal Cancer +1 more
Related terms Carcinoma, Ovarian Epithelial, Endometrial Neoplasms, Fallopian Tube Neoplasms, Hereditary Breast and Ovarian Cancer Syndrome, Myofibroma, Ovarian Neoplasms, Sarcoma, Uterine Cervical Neoplasms, Vaginal Neoplasms, Vulvar Neoplasms
Enrollment 6,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov