PLCO Etiology and Early Marker Studies (EEMS)
To: Potential EEMS Investigator
From: EEMS Coordinating Center
Regarding: PLCO Etiology and Early Marker Studies (EEMS) 2007 Review Cycle
Date: April 16, 2007
This memo is an official announcement that the PLCO EEMS review process will be
accepting proposals for use of the PLCO biorepository materials twice for calendar
year 2007. Applications for the first round for 2007 will be June 1, 2007 through
June 29, 2007 at 5 PM EDST. The second round will be from December 1, 2007 through
December 29, 2007 at 5 PM EST. Another announcement will be sent eight weeks prior
to the open season for receipt of applications in December. We trust that this
advance notice will allow you to plan more appropriately for your research
activities this calendar year. We plan to continue twice yearly rounds for
application acceptance during the months of June and December if budgetary
Please distribute this notice to those individuals with whom you work that may be
interested in submitting an EEMS application.
The Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Trial is a large
population based randomized trial evaluating screening programs for these cancers.
The PLCO Biorepository contains approximately 2.7 million biologic specimens,
including blood specimens collected from intervention participants during their
six trial screening years and buccal cell specimens collected from control
participants. The Etiology and Early Marker Studies (EEMS) is a component of
the PLCO Trial designed to facilitate research in early detection and molecular
epidemiology of cancers using Trial collection specimens.
The EEMS application materials ( the EEMS application forms, instructions,
applicant’s checklist, NIH biosketch, confidentiality disclosure agreement (CDA),
and the EEMS policy document), as well as general information regarding the EEMS
review process can be found under the PLCO EEMS tab on the Program Administrative
Resource (PAR) PLCO website (www.parplco.org). Individuals who do not already have
access to PAR should contact the PAR PLCO Helpdesk (email@example.com)
and request permission to access the EEMS tab on the website. Individuals who
currently have access to PAR should already be able to access to the EEMS tab;
please contact the PAR PLCO Helpdesk (firstname.lastname@example.org) with any problems.
Once your proposal is received, the EEMS Coordinating Center will verify that all
components are completed and forward the completed proposal packet to the EEMS
Principal Investigator, the PLCO Project Officer and Chief Statistician for an
initial suitability review. This initial review will be completed around the
end of August 2007. Potential investigators will be notified of the results
of the suitability review. After the suitability review, the EEMS Review Panel
will review and comment on all suitable proposals. It is anticipated that this
review will be completed by mid–October, contingent upon the quantity of
proposals received. The EEMS PI and the PLCO PO will then make the final
decision regarding all acceptable proposals based on input from the EEMS Review Panel.
Please submit completed proposal application and associated materials to the
EEMS Coordinating Center at the following address:
Confidentiality Agreements (CDA) should be sent to the following address:
Kevin Brand, JD
Technology Transfer Specialist
Technology Transfer Branch
6120 Executive Blvd., Suite 450
Rockville, MD 20852
Phone: (301) 451–4566
Fax: (301) 402–2117
If you have any questions please do not hesitate to contact us. Thank you for your time
and we wish you success in your PLCO related studies.
Christine D. Berg, M.D.
Chief, Early Detection Research Group
PLCO Project Officer
Division of Cancer Prevention, NCI
Executive Plaza North, Suite 3100
6130 Executive Boulevard, MSC 7346
Bethesda, MD 20892–7346
(For FEDEX: Rockville, MD 20852)
Tel: (301) 496–8544
Fax: (301) 480–0465
New Cancer Centers Branch Program Director
Join us in welcoming Dr. Hasnaa Shafik as a new Program Director in the Cancer
Cancers Branch. Dr. Shafik joined the NCI Office of Cancer Complementary and Alternative
Medicine’s program staff in 2003. In early 2005 she assumed a new role as a Scientific
Review Administrator in the NCI Division of Extramural Activities. She was in charge of
the Prevention, Control and Population Sciences Special Emphasis Panel which reviews
Program Projects and multi–site clinical trials.
Dr. Shafik earned her Medical Degree, and Masters in Public Health from Ain Shams
University, Cairo Egypt. Through the Fulbright program she was awarded a fellowship
at the University of Texas Medical Branch in Galveston (UTMB) to study the mechanisms
of induction of cancer with emphasis on chemical carcinogenesis. She then joined the
Graduate School at UTMB and earned a PhD in Preventive Medicine and Community Health
with a major in genetic/environmental toxicology. Dr. Shafik’s research mainly focused
on mechanisms of leukemogenesis in patients with Down syndrome. She identified non–random
chromosomal breakpoints in 16 bands throughout the genome that could be used as a surrogate
for early detection of predisposition to leukemia. She was awarded the March of Dimes’
Birth Defect Foundation Merit Award and Katherina Seibert Award for her research on Down
syndrome and cancer.
Dr Shafik was a faculty member in the medical school in Egypt, and later chaired the
Department of Pathology and Microbiology at Texas Chiropractic College. She had committee
responsibilities nationwide; serving on the Microbiology and Public Health testing committee
in the National Board of Chiropractic examiners and as site team member on the Council on
Chiropractic Education to evaluate basic science programs in chiropractic colleges for accreditation.
Dr. Shafik can be reached by telephone at (301) 496–8531, or via email to
NCI Staff Attends AACR Conference in Los Angeles
Drs. Bhorjee, Ellis, Shafik, and Vembu (CCB Program Directors) and Ms. Patricia Winkler
(CCB IT Specialist/Program Analyst) will be attending the AACR Conference in Los
Angeles in April. If you would like to arrange a meeting with one of our program
directors, or with Ms. Winkler in relation to data summary issues, please contact
Ms. Joyce Linder, our program assistant, at (301) 496–8531. —posted 3/2/2007
New Scientific Review Administrator for Subcommittee A
Dr. Gail Bryant has been appointed as the Scientific Review Administrator for NCI
Initial Review Group Subcommittee A for cancer center reviews. Dr. Bryant’s medical education
and training, extensive translational research experience, and many years of outstanding service
in NCI extramural review activity provide a superb background for this position. In addition,
she has organized and managed site visit reviews for Cancer Center Support Grant applications
for 12 years, receiving accolades from both reviewers and applicants for her work. Further,
she has been closely involved in the management of the Subcommittee and has served as a full
partner in developing and implementing Subcommittee and CCSG review practices and procedures.
The former SRA, Dr. David Maslow, who served for 16 years, has been appointed acting Associate
Director of the NCI Division of Extramural Activities with responsibility for the Office of
Referral, Review and Program Coordination while remaining Chief of the Resources and Training Review Branch.
Cancer Center Directors Working Group Report—posted 12/1/2006
At the November 7, 2006 Center Directors Retreat, a small working group
chaired by Dr. John Mendelsohn was asked to produce a report providing a blueprint
for achievement of a series of goals that included reducing the burden of cancer
through strategies in prevention, detection, treatment, and survivorship and identifying
ways in which NCI–designated Cancer Centers could enhance collaborative activities and
provide leadership in dissemination of best practices. The
final report was presented to the National Cancer Advisory Board this morning
by Drs. Mendelsohn and Abeloff. Also available is a complementary document outlining
survivorship activities at Cancer Centers. You will receive hard copies of these reports
by mail in October.
2006 Annual Report to the Nation
The following press release regarding the 2006 Annual Report to the Nation is now available
In addition, a Q&A regarding the report is available at
You can access the full report at
materials are also available in Spanish at
- posted 9/6/2006
President Bush Appoints Dr. Niederhuber as NCI Director
Yesterday President George W. Bush announced his intent to appoint of John E. Niederhuber, M.D.
as Director of the National Cancer Institute
A nationally renowned surgeon and researcher, Dr. Niederhuber has dedicated his entire academic
career to the treatment and study of cancer - as a professor, cancer center director, National
Cancer Advisory Board chair, external advisor to the NCI, grant reviewer, and laboratory
investigator supported by NCI and the National Institutes of Health. Dr. Niederhuber joined
NCI in September 2005 as NCI's Chief Operating Officer and Deputy Director for Translational
and Clinical Sciences, and was appointed Acting Director in June 2006. Additional information
on Dr. Niederhuber can be found at
- posted 8/16/2006
2007 Cancer Center Directors Retreat
The Spring 2007 Cancer Center Directors Retreat has been scheduled for Monday and Tuesday,
April 30 - May 1st, 2007 at the Doubletree Hotel in Bethesda, Maryland. As with the
May 2006 Retreat, the 2007 meeting will be scheduled to start at approximately 6:00 p.m. on
April 30th and adjourn on the next day at approximately 4 p. m. An agenda and details on
hotel reservations will be posted later.
Please contact our office (301-496-8531) if you have questions. - posted 8/15/2006
Peer Evaluation of Minority/Gender Representation
At the May 1-2, 2006 Center Directors Retreat, we announced a policy clarification for peer
evaluation of minority and gender representation. In keeping with the original legislation,
NIH policy, and CCSG Guidelines, reviewers now will be asked to assess accrual to both
therapeutic and non-therapeutic interventional clinical trials. As a reminder, please note
that per CCSG Guidelines instructions, accrual data for non-interventional studies (e.g.,
epidemiologic, health outcome, observational studies, etc.) are not to be reported.
A Policy Clarification document summarizes the background
for this clarification and provides information on the new approach to review of this component.
Peer reviewers will be apprised of the new approach and will be given this document to use
as a reference. Please contact our office (301-496-8531) if you have questions. - posted 7/3/2006
Registering Trials with the PDQ Registry
The National Cancer Institute’s (NCI’s) PDQ® Cancer Clinical Trials Registry is a searchable
database of more than 3,800 active and 15,000 closed clinical trials available on the NCI
Web site (www.cancer.gov/clinicaltrials).
Patients, physicians, clinical trial support staff,
and researchers perform more than 180,000 searches per month on this site to find clinical
trials. NCI’s Cancer Information Service (1-800-4-Cancer) also uses this database to respond
to more than 8,000 inquiries per year about clinical trials. We encourage your Cancer Center
investigators and clinical trial support staff to take advantage of this service to register
their clinical trials in a publicly accessible database.
Key advantages of registering trials with PDQ include the following:
NCI Office of Communications staff, who maintain the PDQ database, would be happy to meet
with your clinical trial staff to provide more details about registering your trials in PDQ
and the services offered. A
reference document outlines the simple process for registering
trials in PDQ and provides contact information.
- Clinical trials listing prepared at no cost to Cancer Centers. Trained NCI contract staff
summarize key aspects of the protocol, including eligibility criteria, in a standardized manner,
for patients and health professionals. Cancer Center personnel need only provide the protocol
document, a copy of the informed consent, and the approval by an Institutional Review Board to PDQ;
NCI handles the rest.
(See reference document
- Compliance with FDAMA Section 113. NCI registers trials submitted to PDQ with the National
Institute of Health’s ClinicalTrials.gov registry. This enables trial sponsors to meet
regulatory requirement under Section 113 of the Food and Drug Administration Modernization
Act (FDAMA) that requires registration of all Phase II, Phase III, and Phase IV treatment
cancer trials in ClinicalTrials.gov. We also provide investigators with the ClinicalTrials.gov
registration number, the NCTID, which can be used as proof of trial registration when trial
results are submitted to medical journals for publication.
- Compliance with ICMJE requirements for trial registration. The International Committee
of Medical Journal Editors (ICMJE) has made trial registration in a publicly accessible
database a condition for publishing results of clinical trials in major medical journals.
PDQ helps investigators meet this requirement without an additional burden because the trial
listings are provided to ClinicalTrials.gov, the registry identified by ICMJE.
- Identification as NCI-sponsored trials. Trials being conducted with NCI grant funding
are identified as NCI-sponsored trials. This designation is used by the Department of
Veterans Affairs and Department of Defense health systems, as well as by state agencies,
to verify eligibility for insurance reimbursement.
- Greater visibility for trials at Cancer Centers. Besides providing visibility for Cancer
Center trials on the NCI Web site, PDQ Clinical Trials Registry is also licensed to other
major Web-based clinical trials service providers such as EmergingMed (which powers the
American Cancer Society’s clinical trials search), TrialCheck® (Coalition of Cancer Cooperative
Groups’ search engine), and CenterWatch. Cancer Centers can also include links to clinical
trial descriptions in PDQ from their Web sites, without expending resources on creating
We appreciate your cooperation in ensuring that all trials conducted by the NCI-designated
Cancer Centers are registered in PDQ and accessible to cancer patients. Please let us know
how we may be of further assistance. - posted 6/6/2006
First Generation Guidelines for NCI-Supported Biorepositories
In 2002 the NCI launched a multi-year process intended to unify policies and procedures
for NCI-supported biorepositories. This included a 2004 report compiled for the National
Cancer Advisory Board that showed considerable heterogeneity in biorepository management
practices across the Institute. In response to the report, the NCI took several steps,
including the establishment of a Biorepository Coordinating Committee (BCC) in early 2005.
This committee works in an advisory capacity with the NCI Office of Biorepositories and
Biospecimen Research (OBBR)
(http://biospecimens.cancer.gov/), which is headed by Dr. Carolyn Compton, to coordinate
and optimize biospecimen resources for the broad cancer research community. During the
summer of 2005, the BCC and OBBR held two workshops focusing on operational and ethical,
legal and policy issues in biorepository management and biospecimen research. The
workshops included representatives with diverse expertise from the cancer research,
patient advocate, and bioethics communities. The initial outcome of these workshops
is a document entitled First-Generation Guidelines for NCI-Supported Biorepositories.
These Guidelines were approved by the National Cancer Advisory Board at its December 2005
Later this month, an announcement of the Guidelines will be published in the Federal Register
and there will be a period of public comment; they also will be distributed to selected
professional and scientific organizations for distribution to members. It is expected they
will evolve over time with input from the research community and in
response to changing technology and clinical practice. Comments may be forwarded to the
OBBR office at
email@example.com. - posted 12/1/2005
Discontinuation of Mailed Summary Statements
Effective October 1, 2005, the NIH discontinued mailing of hard copies of Summary Statements
including those for P30 Cancer Center Support Grant applications. Investigators are
now instructed to use the eRA Commons, a Web interface for electronic conduct of
business between the NIH and applicant organizations, to retrieve these statements.
Applicant organizations must be registered in the eRA Commons before an account can be
established for the investigators and e-notification of Summary Statement availability
can occur. Your institutional Office of Sponsored Research Programs should be able
to provide guidance on registration procedures if you are not already registered. - posted 9/8/2005