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follow-up of abnormal CA 125 levels in patients in the PLCO trial

Principal Investigator
Name
Keith Terada
Degrees
M.D.
Institution
University of Hawaii
Position Title
Assoc. Prof.
Email
About this CDAS Project
Study
PLCO (Learn more about this study)
Project ID
PLCO-3
Initial CDAS Request Approval
Nov 14, 2012
Title
follow-up of abnormal CA 125 levels in patients in the PLCO trial
Summary
CA-125 is commonly utilized as a marker for ovarian cancer. The PLCO trial analyzed CA-125 as a possible screening test for ovarian cancer. Previously published data noted that there were 1035 women with an abnormal CA 125 at screening in the PLCO study. Of these 927 had a normal ultrasound, 134 of these patients underwent a diagnostic procedure and were not diagnosed with invasive ovarian, peritoneal, or fallopian tube cancer. Of these 13 were found to have non-ovarian cancers. The outcome of the remaining patients has not been studied. The current study proposes to analyze longitudinal follow-up of patients with an abnormal CA 125 level.
In the previously published study by Johnson et al., abnormal CA 125 levels were associated with increasing age, previous hysterectomy, smoking history, and obesity. We also propose to examine all cause mortality and cancer specific mortality in these groups of patients with an abnormal CA 125.
Specifically, we wish to determine the long term outcome of an abnormal CA 125 level associated with a normal ultrasound. We propose to determine what proportion remain persistently abnormal and whether there is any clinical significance to a persistently abnormal CA 125. We seek to determine long term outcome and analyze all-cause mortality in women with an abnormal CA 125, particularly for subgroups previously identified as being associated with abnormal CA 125 levels. In addition we also wish to analyze patients with subsequent normalization of an abnormal CA 125 level. What is the time course for normalization and are there adverse health consequences of a transiently elevated CA 125?
The current study will analyze the entire population with abnormal CA 125 and normal ultrasound at screening to address the following questions:
-What proportion of abnormal CA 125 levels will normalize at follow-up? What is the time course for normalization? What is all cause mortality and cancer specific mortality in this group of patients?
-Is there any clinical significance to a persistently abnormal CA 125 with a normal ultrasound? What is all cause mortality and cancer specific mortality in this group of patients? We also wish to stratify this into subgroups of increasing age, previous hysterectomy, smoking history, and obesity.
-The population of screened patients with a normal screen will be used as a comparison/control group for comparing all cause mortality and cancer specific mortality.
Aims

The specific aims of the study will be to analyze CA 125 follow-up and mortality in the population of screened females. Data to be abstracted includes patient age, previous smoking history, obesity, previous hysterectomy, vital status, and cause of death. Patients diagnosed specifically with cancer of the ovary, peritoneum, fallopian tube will be excluded from the analysis. Longitudinal follow-up of CA 125 levels will be performed. We will then compare all cause mortality and cancer specific mortality in patients with normal CA 125 levels vs. patients with abnormal CA 125 levels. Subgroup analysis will then be performed for patients with transiently abnormal CA 125 levels, and patients with persistently abnormal CA 125 levels. We will also compare patients with each of the following characteristics: previous smoking history, obesity, increasing age, and previous hysterectomy. A comparison of all cause mortality and cancer specific mortality will then be performed for patients with abnormal vs. normal CA 125 levels in each of these 4 subgroups.

Collaborators

Michael Carney, M.D. University of Hawaii School of Medicine
Robert Kim, M.D. University of Hawaii School of Medicine

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