Screening for Ovarian Cancer in Older Patients (PLCO Screening Trial)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01696994
First received: September 28, 2012
Last updated: July 5, 2016
Last verified: July 2016
Results First Received: August 30, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Investigator);   Primary Purpose: Screening
Conditions: Ovarian Carcinoma
Ovarian Germ Cell Tumor
Interventions: Other: Laboratory Biomarker Analysis
Other: Screening Questionnaire Administration
Procedure: Ultrasonography

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were enrolled between November 1993 and July 2001 at 10 study centers.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants signed a study informed consent prior to being randomized to a study arm.

Reporting Groups
  Description
Control Participants receive standard medical care.
Ovarian Screening Participants undergo blood sample collection for CA-125 analysis at baseline annually for 5 years. Participants also undergo an OVR (discontinued in December 1998) and TVU at baseline and annually for 3 years.

Participant Flow:   Overall Study
    Control     Ovarian Screening  
STARTED     39111     39105  
COMPLETED     33919     30668  
NOT COMPLETED     5192     8437  
Cancer Before Rand. (Ovarian Screening)                 0                 2  
Died Before Randomization                 1                 2  
Died Before ASU (Control)                 73                 0  
No Ovaries at Baseline                 4807                 4851  
Refused ASU (Control)                 311                 0  
Refused Screen (Ovarian Screening)                 0                 3582  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Control Participants receive standard medical care. Participants complete a baseline questionnaire (BQ) at entry and a dietary history questionnaire (DHQ) during study years 0-6.
Ovarian Screening Participants undergo blood sample collection for Cancer Antigen 125 (CA-125) analysis at baseline and annually for 5 years. Participants also undergo an OVR (discontinued in December 1998) and TVU at baseline and annually for 3 years.
Total Total of all reporting groups

Baseline Measures
    Control     Ovarian Screening     Total  
Number of Participants  
[units: participants]
  39111     39105     78216  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     25222     25233     50455  
>=65 years     13889     13872     27761  
Age  
[units: years]
Mean (Standard Deviation)
  62.5  (5.4)     62.5  (5.4)     62.5  (5.4)  
Gender  
[units: participants]
     
Female     39111     39105     78216  
Male     0     0     0  
Region of Enrollment  
[units: participants]
     
United States     39111     39105     78216  



  Outcome Measures
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1.  Primary:   Ovarian Cancer Deaths (Including Primary Peritoneal and Fallopian Tube Cancers)   [ Time Frame: Events through 13 years of follow-up or through December 31, 2009; median follow-up 11.9 years. ]

2.  Primary:   Ovarian Cancer Death Rates (Including Primary Peritoneal and Fallopian Tube Cancers)   [ Time Frame: Events through 13 years of follow-up or through December 31, 2009; median follow-up 11.9 years. ]

3.  Secondary:   Deaths From All Causes   [ Time Frame: Events through 13 years of follow-up or through December 31, 2009; median follow-up 11.9 years. ]

4.  Secondary:   Death Rates From All Causes   [ Time Frame: Events through 13 years of follow-up or through December 31, 2009; median follow-up 11.9 years. ]

5.  Secondary:   Ovarian Cancer Incidence (Including Primary Peritoneal and Fallopian Tube Cancers)   [ Time Frame: Events through 13 years of follow-up or through December 31, 2009; median follow-up 11.9 years. ]

6.  Secondary:   Ovarian Cancer Incidence Rates (Including Primary Peritoneal and Fallopian Tube Cancers).   [ Time Frame: Events through 13 years of follow-up or through December 31, 2009; median follow-up 11.9 years. ]

7.  Secondary:   Complications of Diagnostic Evaluation (DE) Following a Positive Screening Test   [ Time Frame: One year from screening examination ]

8.  Secondary:   T0 (Baseline) CA-125 Screening Results   [ Time Frame: T0 (at study entry) ]

9.  Secondary:   T0 (Baseline) TVU Screening Results   [ Time Frame: T0 (at study entry) ]

10.  Secondary:   T1 CA-125 Screening Results   [ Time Frame: T1 (one year after entry) ]

11.  Secondary:   T1 TVU Screening Results   [ Time Frame: T1 (one year after entry) ]

12.  Secondary:   T2 CA-125 Screening Results   [ Time Frame: T2 (two years after entry) ]

13.  Secondary:   T2 TVU Screening Results   [ Time Frame: T2 (one year after entry) ]

14.  Secondary:   T3 CA-125 Screening Results   [ Time Frame: T3 (three years after entry) ]

15.  Secondary:   T3 TVU Screening Results   [ Time Frame: T3 (three years after entry) ]

16.  Secondary:   T4 CA-125 Screening Results   [ Time Frame: T4 (four years after entry) ]

17.  Secondary:   T5 CA-125 Screening Results   [ Time Frame: T5 (five years after entry) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Paul F. Pinsky, Ph.D.
Organization: Early Detection Research Group, NCI, NIH
phone: 301-496-8544
e-mail: pinskyp@mail.nih.gov



Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01696994     History of Changes
Other Study ID Numbers: NCI-2012-01758
NCI-2012-01758 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
PLCO-1
CDR0000078532
NCI-P93-0050
PLCO-Ovarian ( Other Identifier: National Institutes of Health Clinical Center )
Study First Received: September 28, 2012
Results First Received: August 30, 2013
Last Updated: July 5, 2016
Health Authority: United States: Institutional Review Board