PLCO PAR-13-036 Preliminary Application Form
A.1 DATE OF SUBMISSION: |__|__| / |__|__| / 20|__|__|
Month Day
Year
A.3 PROJECT TITLE: _____________________________________________________________________________
A.4 CORRESPONDING INVESTIGATOR: ______________________________________
Affiliation
Institution:
Street:
City:
State
B.
________________________________________
________________________________________
________________________________________
___________________Zip: _________________
Phone:
|__|__|__|-|__|__|__|-|__|__|__|__|
Fax:
E-mail:
|__|__|__|-|__|__|__|-|__|__|__|__|
_____________________________________
RESEARCH PROJECT INFORMATION:
B. 1 STUDY SYNOPSIS:
Provide a paragraph briefly describing your study and goals.
B.2 SPECIFIC AIMS OF THE PROPOSAL:
Provide one to two paragraphs describing the specific aims of the study, including the hypothesis to be tested
C.
WHAT IS YOUR STUDY POPULATION? (PRELIMINARY ESTIMATE):
Provide as much detail as possible about your study population, its components and what defines each component.
Example: 100
Total # of Cases:
Example: 300
Total # of Controls:
Example: Prostate cancer with biopsy Gleason score >7
What is your definition of a Case?
Example: Men without any cancer
What is your definition of a
Control?
Example: Age, time in storage, study year
What are your matching criteria, if
any?
Example: 10% of the subjects randomly selected from the controls
What QC samples will you include?
D.
WHAT ARE THE BIOLOGIC SPECIMENS REQUIRED? (PRELIMINARY ESTIMATE):
Provide a listing of the specimens needed by completing the table below.
Specimen Type
Time from sample
collection to
diagnosis*
(cases only)
Desired Specimen
Volume or
Quantity
Case
Serum
Less than two year
200ul
Male
Control
Serum
N/A
200ul
Example: 100
Male
case
Any DNA Source
(Buffy Coat or Whole
Blood)
Any
1ug
Example: 300
Male
control
Any DNA Source
(Buffy Coat or Whole
Blood)
Any
1ug
Population
Size
Covariate
(if any)
Case/
Control
Example: 100
Male
Example: 300
Analytes
free PSA, total PSA,
intact PSA, hK2
free PSA, total PSA,
intact PSA, hK2
E50 SNPs (details of
the SNPs are
indicated on attached
table)
50 SNPs (details of
the SNPs are
indicated on attached
table)
*The PLCO blood specimens are collected prospectively at each screening visit (years 0-5). As such, the specimens are (generally)
collected when subjects are asymptomatic and before they are diagnosed with (or worked up for a diagnosis of) cancer. These
specimens are referred to as “pre-diagnostic”. In general, pre-diagnostic blood specimens are available from multiple time points for a
given subject, and thus subjects generally have blood specimens with varying time intervals from collection to diagnosis.
Therefore, when designing a study using PLCO blood specimens for biochemical analyses, investigators must consider the timing of
the blood collection in relation to diagnosis, and choose the sample with the most appropriate timing that is consistent with the study
aims. For example, for a study of early detection biomarkers for cancer, an investigator should consider using specimens closer to
diagnosis, say within 1-2 years prior to diagnosis, when the tumor has developed but is still preclinical. For a study of etiologic
biomarkers, on the other hand, an investigator should consider using specimens further away from diagnosis, say more than 3 years
prior to diagnosis, when the subject is still at risk for developing, but has not developed, the tumor yet.
Return completed form to zhucla@mail.nih.gov
For Administrative Use Only
Approved ☐
Disapproved ☐
Date |__||__| |__|__| |__|__|__|__|
Month Day Year
Study ID Number: |__|__|__|__| - |__|__|__|