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Trial record 84 of 121 for:    prostate cancer AND prostate cancer screening | ( Map: United States )

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

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ClinicalTrials.gov Identifier: NCT01696981
Recruitment Status : Unknown
Verified June 2017 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : October 2, 2012
Results First Posted : July 21, 2014
Last Update Posted : August 12, 2019
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Investigator);   Primary Purpose: Screening
Conditions Colon Carcinoma
Rectal Carcinoma
Interventions Other: Screening Questionnaire Administration
Procedure: Sigmoidoscopy
Enrollment 154900
Recruitment Details Participants were enrolled between November 1993 and July 2001 at 10 study centers. Recruitment was done for all four outcomes of the study (prostate, lung, colorectal and ovarian).
Pre-assignment Details Participants signed a study informed consent prior to being randomized to a study arm.
Arm/Group Title Control Colorectal Screening
Hide Arm/Group Description Participants receive standard medical care. Participants complete a baseline questionnaire at entry and a dietary history questionnaire (DHQ) during study years 0-6. Participants undergo a colorectal examination with a flexible sigmoidoscope at baseline and year 5. Participants complete a Dietary Questionnaire (DQX) at baseline and a Dietary History Questionnaire (DHQ) at study years 3-6. An Annual Study Update (ASU) (previously referred to as the Periodic Survey of Health [PSH] questionnaire) is mailed to each participant annually for 13 years to identify all prevalent and incident colorectal cancers and all deaths that occur among both screened and control arm subjects during the trial.
Period Title: Overall Study
Started 77455 77445
Completed 76254 67071
Not Completed 1201 10374
Reason Not Completed
Cancer Before Rand. (Colo. Screening)             0             20
Died Before Randomization             3             8
Died Before ASU (Control)             278             0
Refused ASU (Control)             920             0
Refused Screen (Colorectal Screening)             0             10346
Arm/Group Title Control Colorectal Screening Total
Hide Arm/Group Description Participants receive standard medical care. Participants complete a baseline questionnaire at entry and a dietary history questionnaire (DHQ) during study years 0-6. Participants undergo a colorectal examination with a flexible sigmoidoscope at baseline and year 5. Participants complete a Dietary Questionnaire (DQX) at baseline and a Dietary History Questionnaire (DHQ) at study years 3-6. An Annual Study Update (ASU) (previously referred to as the Periodic Survey of Health [PSH] questionnaire) is mailed to each participant annually for 13 years to identify all prevalent and incident colorectal cancers and all deaths that occur among both screened and control arm subjects during the trial. Total of all reporting groups
Overall Number of Baseline Participants 77455 77445 154900
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 77455 participants 77445 participants 154900 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
49610
  64.1%
49634
  64.1%
99244
  64.1%
>=65 years
27845
  35.9%
27811
  35.9%
55656
  35.9%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 77455 participants 77445 participants 154900 participants
62.6  (5.4) 62.6  (5.4) 62.6  (5.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 77455 participants 77445 participants 154900 participants
Female
39111
  50.5%
39105
  50.5%
78216
  50.5%
Male
38344
  49.5%
38340
  49.5%
76684
  49.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 77455 participants 77445 participants 154900 participants
77455 77445 154900
1.Primary Outcome
Title Colorectal Cancer Deaths
Hide Description Colorectal cancer deaths confirmed in participants by a death review committee if available, otherwise by death certificate.
Time Frame Events through 13 years of follow-up or through December 31, 2009; median follow-up 12.1 years.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Colorectal Screening
Hide Arm/Group Description:
Participants receive standard medical care. Participants complete a baseline questionnaire at entry and a dietary history questionnaire (DHQ) during study years 0-6.
Participants undergo a colorectal examination with a flexible sigmoidoscope at baseline and year 5. Participants complete a Dietary Questionnaire (DQX) at baseline and a Dietary History Questionnaire (DHQ) at study years 3-6. An Annual Study Update (ASU) (previously referred to as the Periodic Survey of Health [PSH] questionnaire) is mailed to each participant annually for 13 years to identify all prevalent and incident colorectal cancers and all deaths that occur among both screened and control arm subjects during the trial.
Overall Number of Participants Analyzed 77455 77445
Measure Type: Number
Unit of Measure: Participants
341 252
2.Primary Outcome
Title Colorectal Cancer Death Rates
Hide Description Colorectal cancer deaths confirmed in participants by a death review committee if available, otherwise by death certificate. Rate is the number of deaths divided by person years of follow-up in the study.
Time Frame Events through 13 years of follow-up or through December 31, 2009; median follow-up 12.1 years.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Colorectal Screening
Hide Arm/Group Description:
Participants receive standard medical care. Participants complete a baseline questionnaire at entry and a dietary history questionnaire (DHQ) during study years 0-6.
Participants undergo a colorectal examination with a flexible sigmoidoscope at baseline and year 5. Participants complete a Dietary Questionnaire (DQX) at baseline and a Dietary History Questionnaire (DHQ) at study years 3-6. An Annual Study Update (ASU) (previously referred to as the Periodic Survey of Health [PSH] questionnaire) is mailed to each participant annually for 13 years to identify all prevalent and incident colorectal cancers and all deaths that occur among both screened and control arm subjects during the trial.
Overall Number of Participants Analyzed 77455 77445
Measure Type: Number
Unit of Measure: Deaths per 10,000 PY
3.9 2.9
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control, Colorectal Screening
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Poisson regression
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.74
Confidence Interval (2-Sided) 95%
0.63 to 0.87
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Deaths From All Causes
Hide Description Deaths from all causes were compared between the colorectal cancer screening arm and the usual care arm.
Time Frame Events through 13 years of follow-up or through December 31, 2009; median follow-up 12.1 years.
Hide Outcome Measure Data
Hide Analysis Population Description
All participants. An intention-to-treat analysis was performed.
Arm/Group Title Control Colorectal Screening
Hide Arm/Group Description:
Participants receive standard medical care. Participants complete a baseline questionnaire at entry and a dietary history questionnaire (DHQ) during study years 0-6.
Participants undergo a colorectal examination with a flexible sigmoidoscope at baseline and year 5. Participants complete a Dietary Questionnaire (DQX) at baseline and a Dietary History Questionnaire (DHQ) at study years 3-6. An Annual Study Update (ASU) (previously referred to as the Periodic Survey of Health [PSH] questionnaire) is mailed to each participant annually for 13 years to identify all prevalent and incident colorectal cancers and all deaths that occur among both screened and control arm subjects during the trial.
Overall Number of Participants Analyzed 77455 77445
Measure Type: Number
Unit of Measure: Participants
11064 10835
4.Secondary Outcome
Title Death Rates From All Causes
Hide Description Deaths from all causes were compared between the colorectal cancer screening arm and the usual care arm. Rate is the number of deaths divided by person years of follow-up in the study.
Time Frame Events through 13 years of follow-up or through December 31, 2009; median follow-up 12.1 years.
Hide Outcome Measure Data
Hide Analysis Population Description
All participants. An intention-to-treat analysis was performed.
Arm/Group Title Control Colorectal Screening
Hide Arm/Group Description:
Participants receive standard medical care. Participants complete a baseline questionnaire at entry and a dietary history questionnaire (DHQ) during study years 0-6.
Participants undergo a colorectal examination with a flexible sigmoidoscope at baseline and year 5. Participants complete a Dietary Questionnaire (DQX) at baseline and a Dietary History Questionnaire (DHQ) at study years 3-6. An Annual Study Update (ASU) (previously referred to as the Periodic Survey of Health [PSH] questionnaire) is mailed to each participant annually for 13 years to identify all prevalent and incident colorectal cancers and all deaths that occur among both screened and control arm subjects during the trial.
Overall Number of Participants Analyzed 77455 77445
Measure Type: Number
Unit of Measure: Deaths per 10,000 PY
127.0 124.3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control, Colorectal Screening
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Poisson regression
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.98
Confidence Interval (2-Sided) 95%
0.95 to 1.00
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Colorectal Cancer Incidence
Hide Description Colorectal cancer diagnoses confirmed by medical record abstraction.
Time Frame Events through 13 years of follow-up or through December 31, 2009; median follow-up 12.1 years.
Hide Outcome Measure Data
Hide Analysis Population Description
All participants. An intention-to-treat analysis was performed.
Arm/Group Title Control Colorectal Screening
Hide Arm/Group Description:
Participants receive standard medical care. Participants complete a baseline questionnaire at entry and a dietary history questionnaire (DHQ) during study years 0-6.
Participants undergo a colorectal examination with a flexible sigmoidoscope at baseline and year 5. Participants complete a Dietary Questionnaire (DQX) at baseline and a Dietary History Questionnaire (DHQ) at study years 3-6. An Annual Study Update (ASU) (previously referred to as the Periodic Survey of Health [PSH] questionnaire) is mailed to each participant annually for 13 years to identify all prevalent and incident colorectal cancers and all deaths that occur among both screened and control arm subjects during the trial.
Overall Number of Participants Analyzed 77455 77445
Measure Type: Number
Unit of Measure: Participants
1287 1012
6.Secondary Outcome
Title Colorectal Cancer Incidence Rates
Hide Description Colorectal cancer diagnoses confirmed by medical record abstraction. Incidence rate (cumulative) defined as colorectal cancer diagnoses divided by person years at risk for colorectal cancer.
Time Frame Events through 13 years of follow-up or through December 31, 2009; median follow-up 12.1 years.
Hide Outcome Measure Data
Hide Analysis Population Description
All participants. An intention-to-treat analysis was performed.
Arm/Group Title Control Colorectal Screening
Hide Arm/Group Description:
Participants receive standard medical care. Participants complete a baseline questionnaire at entry and a dietary history questionnaire (DHQ) during study years 0-6.
Participants undergo a colorectal examination with a flexible sigmoidoscope at baseline and year 5. Participants complete a Dietary Questionnaire (DQX) at baseline and a Dietary History Questionnaire (DHQ) at study years 3-6. An Annual Study Update (ASU) (previously referred to as the Periodic Survey of Health [PSH] questionnaire) is mailed to each participant annually for 13 years to identify all prevalent and incident colorectal cancers and all deaths that occur among both screened and control arm subjects during the trial.
Overall Number of Participants Analyzed 77455 77445
Measure Type: Number
Unit of Measure: Diagnoses per 10,000 PY
15.2 11.9
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control, Colorectal Screening
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Poisson regression
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.79
Confidence Interval (2-Sided) 95%
0.72 to 0.85
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Complications of Diagnostic Evaluation Following a Positive Screening Test
Hide Description Number of participants who experienced complications during diagnostic work-up of a positive colorectal examination.
Time Frame One year from screening examination
Hide Outcome Measure Data
Hide Analysis Population Description
The units analyzed were positive screening exams with documented diagnostic follow-up. If a participant received 2 positive screens with documented follow-up after each one, he would be counted 2 times in the number of units analyzed.
Arm/Group Title Colorectal Screening
Hide Arm/Group Description:
Participants undergo a colorectal examination with a flexible sigmoidoscope at baseline and year 5. Participants complete a Dietary Questionnaire (DQX) at baseline and a Dietary History Questionnaire (DHQ) at study years 3-6. An Annual Study Update (ASU) (previously referred to as the Periodic Survey of Health [PSH] questionnaire) is mailed to each participant annually for 13 years to identify all prevalent and incident colorectal cancers and all deaths that occur among both screened and control arm subjects during the trial.
Overall Number of Participants Analyzed 21896
Overall Number of Units Analyzed
Type of Units Analyzed: Positive Screens with Follow-up
24976
Measure Type: Number
Unit of Measure: Positive screens w/ complications
When DE Led to Colorectal Cancer Diagnosis 58
When DE Did Not Lead to Colorectal Cancer Diag 279
8.Secondary Outcome
Title T0 (Baseline) FSG Screening Results
Hide Description Flexible sigmoidoscopy (FSG) result
Time Frame T0 (at study entry)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in the Colorectal Screening arm who had an FSG at T0 were analyzed.
Arm/Group Title Colorectal Screening
Hide Arm/Group Description:
Participants undergo a colorectal examination with a flexible sigmoidoscope at baseline and year 5. Participants complete a Dietary Questionnaire (DQX) at baseline and a Dietary History Questionnaire (DHQ) at study years 3-6. An Annual Study Update (ASU) (previously referred to as the Periodic Survey of Health [PSH] questionnaire) is mailed to each participant annually for 13 years to identify all prevalent and incident colorectal cancers and all deaths that occur among both screened and control arm subjects during the trial.
Overall Number of Participants Analyzed 64653
Measure Type: Number
Unit of Measure: Participants
Negative 42403
Positive 15154
Inadequate screen 7096
9.Secondary Outcome
Title T3/T5 FSG Screening Result
Hide Description Flexible sigmoidoscopy (FSG) result
Time Frame T3 (three years after entry) or T5 (five years after entry)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in the Colorectal Screening arm who had an FSG at T0 or T3 were analyzed.
Arm/Group Title Colorectal Screening
Hide Arm/Group Description:
Participants undergo a colorectal examination with a flexible sigmoidoscope at baseline and year 5. Participants complete a Dietary Questionnaire (DQX) at baseline and a Dietary History Questionnaire (DHQ) at study years 3-6. An Annual Study Update (ASU) (previously referred to as the Periodic Survey of Health [PSH] questionnaire) is mailed to each participant annually for 13 years to identify all prevalent and incident colorectal cancers and all deaths that occur among both screened and control arm subjects during the trial.
Overall Number of Participants Analyzed 41858
Measure Type: Number
Unit of Measure: Participants
Negative 26694
Positive 9818
Inadequate screen 5346
Time Frame During each annual screening visit.
Adverse Event Reporting Description These events are solely those prompted by the screening examination.
 
Arm/Group Title Colorectal Screening
Hide Arm/Group Description Participants undergo a colorectal examination with a flexible sigmoidoscope at baseline and year 5. Participants complete a Dietary Questionnaire (DQX) at baseline and a Dietary History Questionnaire (DHQ) at study years 3-6. An Annual Study Update (ASU) (previously referred to as the Periodic Survey of Health [PSH] questionnaire) is mailed to each participant annually for 13 years to identify all prevalent and incident colorectal cancers and all deaths that occur among both screened and control arm subjects during the trial.
All-Cause Mortality
Colorectal Screening
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Colorectal Screening
Affected / at Risk (%) # Events
Total   0/77445 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Colorectal Screening
Affected / at Risk (%) # Events
Total   504/77445 (0.65%)    
General disorders   
Anxiety *  2/77445 (0.00%)  2
Bleeding *  53/77445 (0.07%)  53
Dizzy *  204/77445 (0.26%)  210
Fainted *  101/77445 (0.13%)  101
Nausea *  101/77445 (0.13%)  101
Pain *  41/77445 (0.05%)  42
Perforated Bowel *  3/77445 (0.00%)  3
Other Adverse Event *  7/77445 (0.01%)  7
*
Indicates events were collected by non-systematic assessment
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Paul F. Pinsky, Ph.D.
Organization: Early Detection Research Group, NCI, NIH
Phone: 301-496-8544
EMail: pinskyp@mail.nih.gov
Layout table for additonal information
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01696981     History of Changes
Other Study ID Numbers: NCI-2012-01757
NCI-2012-01757 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000078532
NCI-P93-0050
PLCO-1
PLCO-Colorectal ( Other Identifier: National Institutes of Health Clinical Center )
First Submitted: September 28, 2012
First Posted: October 2, 2012
Results First Submitted: August 30, 2013
Results First Posted: July 21, 2014
Last Update Posted: August 12, 2019