Notice2024-16973
Supplemental Evidence and Data Request on Blood-Based Tests for Multiple Cancer Screening: A Systematic Review
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
August 1, 2024
Issuing agencies
Health and Human Services DepartmentAgency for Healthcare Research and Quality
Abstract
The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from the public. Scientific information is being solicited to inform our review on Blood-based Tests for Multiple Cancer Screening: A Systematic Review, which is currently being conducted by the AHRQ's Evidence-based Practice Centers (EPC) Program. Access to published and unpublished pertinent scientific information will improve the quality of this review.
Full Text
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<title>Federal Register, Volume 89 Issue 148 (Thursday, August 1, 2024)</title>
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[Federal Register Volume 89, Number 148 (Thursday, August 1, 2024)]
[Notices]
[Pages 62746-62748]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-16973]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality
Supplemental Evidence and Data Request on Blood-Based Tests for
Multiple Cancer Screening: A Systematic Review
AGENCY: Agency for Healthcare Research and Quality (AHRQ), HHS.
ACTION: Request for supplemental evidence and data submission.
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SUMMARY: The Agency for Healthcare Research and Quality (AHRQ) is
seeking scientific information submissions from the public. Scientific
information is being solicited to inform our review on Blood-based
Tests for Multiple Cancer Screening: A Systematic Review, which is
currently being conducted by the AHRQ's Evidence-based Practice Centers
(EPC) Program. Access to published and unpublished pertinent scientific
information will improve the quality of this review.
DATES: Submission Deadline on or before September 3, 2024.
ADDRESSES:
Email submissions: <a href="/cdn-cgi/l/email-protection#593c293a1938312b287731312a773e362f"><span class="__cf_email__" data-cfemail="96f3e6f5d6f7fee4e7b8fefee5b8f1f9e0">[email protected]</span></a>.
Print submissions:
Mailing Address: Center for Evidence and Practice Improvement,
Agency for Healthcare Research and Quality, ATTN: EPC SEADs
Coordinator, 5600 Fishers Lane, Mail Stop 06E53A, Rockville, MD 20857.
Shipping Address (FedEx, UPS, etc.): Center for Evidence and
Practice Improvement, Agency for Healthcare Research and Quality, ATTN:
EPC SEADs Coordinator, 5600 Fishers Lane, Mail Stop 06E77D, Rockville,
MD 20857.
FOR FURTHER INFORMATION CONTACT: Kelly Carper, Telephone: 301-427-1656
or Email: <a href="/cdn-cgi/l/email-protection#5633263516373e2427783e3e2578313920"><span class="__cf_email__" data-cfemail="bcd9ccdffcddd4cecd92d4d4cf92dbd3ca">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: The Agency for Healthcare Research and
Quality has commissioned the Evidence-based Practice Centers (EPC)
Program to complete a review of the evidence for Blood-based Tests for
Multiple Cancer Screening: A Systematic Review. AHRQ is conducting this
review pursuant to Section 902 of the Public Health Service Act, 42
U.S.C. 299a.
The EPC Program is dedicated to identifying as many studies as
possible that are relevant to the questions for each of its reviews. In
order to do so, we are supplementing the usual manual and electronic
database searches of the literature by requesting information from the
public (e.g., details of studies conducted). We are looking for studies
that report on Blood-based Tests for Multiple Cancer Screening: A
Systematic Review. The entire research protocol is available online at:
<a href="https://effectivehealthcare.ahrq.gov/products/cell-free-dna/protocol">https://effectivehealthcare.ahrq.gov/products/cell-free-dna/protocol</a>.
This is to notify the public that the EPC Program would find the
following information on Blood-based Tests for Multiple Cancer
Screening: A Systematic Review helpful:
[ssquf] A list of completed studies that your organization has
sponsored for this topic. In the list, please indicate whether results
are available on <a href="http://ClinicalTrials.gov">ClinicalTrials.gov</a> along with the <a href="http://ClinicalTrials.gov">ClinicalTrials.gov</a>
trial number.
[ssquf] For completed studies that do not have results on
<a href="http://ClinicalTrials.gov">ClinicalTrials.gov</a>, a summary, including the following elements, if
relevant: study number, study period, design, methodology, indication
and diagnosis, proper use instructions, inclusion and exclusion
criteria, primary and secondary outcomes, baseline characteristics,
number of patients screened/eligible/enrolled/lost to follow-up/
withdrawn/analyzed, effectiveness/efficacy, and safety results.
[ssquf] A list of ongoing studies that your organization has
sponsored for this topic. In the list, please provide the
<a href="http://ClinicalTrials.gov">ClinicalTrials.gov</a> trial number or, if the trial is not registered, the
protocol for the study including, if relevant, a study number, the
study period, design, methodology, indication and diagnosis, proper use
instructions, inclusion and exclusion criteria, and primary and
secondary outcomes.
[ssquf] Description of whether the above studies constitute ALL
Phase II and above clinical trials sponsored by your organization for
this topic and an index outlining the relevant information in each
submitted file.
Your contribution is very beneficial to the Program. Materials
submitted must be publicly available or able to be made public.
Materials that are considered confidential; marketing materials; study
[[Page 62747]]
types not included in the review; or information on topics not included
in the review cannot be used by the EPC Program. This is a voluntary
request for information, and all costs for complying with this request
must be borne by the submitter.
The draft of this review will be posted on AHRQ's EPC Program
website and available for public comment for a period of 4 weeks. If
you would like to be notified when the draft is posted, please sign up
for the email list at: <a href="https://effectivehealthcare.ahrq.gov/email-updates">https://effectivehealthcare.ahrq.gov/email-updates</a>.
The review will answer the following questions. This information is
provided as background. AHRQ is not requesting that the public provide
answers to these questions.
Key Questions (KQ)
KQ 1: What is the effectiveness of screening with blood-based
multicancer screening tests (MCST) on cancer-specific mortality and
all-cause mortality?
KQ 2a: What is the effectiveness of screening with MCSTs on the
cumulative detection of cancer overall and by cancer type?
KQ 2b: What is the effectiveness of screening with MCSTs on the
cumulative detection of late-stage cancer (i.e., stage shift) overall
and by cancer type?
KQ 3: What is the accuracy of MCSTs for detection of cancer and
does accuracy vary by cancer type or stage?
KQ 4: What are the harms of screening with MCSTs?
KQ 5: What are the harms of the evaluation and additional testing
following a positive MCST or with surveillance following a negative
evaluation after a positive MCST?
PICOTS (Populations, Interventions, Comparators, Outcomes, Timing, and
Setting)
[Detailed inclusion and exclusion criteria for systematic review on
blood-based tests for multiple cancer screening]
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Inclusion criteria Exclusion criteria
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Population
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KQs 1, 2, 4, 5......................... All KQ: People younger than 18
Asymptomatic people 18 years of age or years of age; other than human
older. populations (e.g., animal or
KQ 3: People 18 years of age or older in vitro laboratory studies).
with either (1) biopsy-confirmed KQs 1, 2, 4, 5: Adults with
cancer or (2) who are asymptomatic active cancer; adults
without suspicion for cancer (i.e., undergoing evaluation for
``healthy'' individuals). suspected cancer or cancer
recurrence; adults with a
history of invasive or
hematologic cancer (other than
nonmelanoma skin cancer)
within the previous 3 years or
a history of untreated cancer.
KQ 3: Adults undergoing
diagnostic evaluation for
possible cancer or cancer
recurrence.
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Intervention
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KQs 1, 2, 3, 4......................... KQs 1, 2, 3, 4: Tests that are
<bullet> Blood tests used for the not blood based (e.g., tissue,
screening of at least 2 different saliva, urine, or other bodily
types of cancer; tests using any fluids).
analytes with any technology are KQ 5: Tests or interventions
eligible. not performed as a result of a
<bullet> Tests that were designed for positive MCST.
cancer prognosis or surveillance in
those with cancer or who have
completed cancer treatment (i.e.,
evaluation for minimal residual
disease) are eligible as long as they
are being evaluated in an eligible
population as defined above.
<bullet> Blood tests used in
combination with other tests such as
imaging are eligible.
<bullet> MCSTs used instead of or in
addition to usual care screening are
eligible. We define usual care
screening as follows: mammography
(breast), direct visualization such as
colonoscopy or stool-based tests
(colorectal), low-dose computed
tomography (lung), cytology, human
papilloma virus testing (cervical),
and prostate specific antigen
(prostate).
KQ 5: Tests or procedures (imaging,
tissue biopsy, blood, urine, or
cerebrospinal fluid) to evaluate
positive signal(s) resulting from an
MCST or procedures used to surveil
patients who have a negative
evaluation after a positive MCST
signal.
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Comparator
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KQs 1, 2, 4............................ KQs 1, 2, 4: No comparator
<bullet> No screening test............. group.
<bullet> Usual care cancer screening as KQ 3: No reference standard for
defined above. comparison.
KQ 3: Tissue evaluation for KQ 5: Studies without a
confirmation of cancer; healthy comparator group will not be
asymptomatic status for controls. excluded.
KQ 5: No comparator required...........
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Outcomes
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KQ 1: Cancer mortality overall and by Outcomes not specifically
cancer type, all-cause mortality, indicated as included.
quality of life, functional status. Composite measures composed of
KQ 2a: Cumulative detection of cancer both included and excluded
overall and by cancer type. outcomes will be included but
KQ 2b: Cumulative detection of late- considered only in sensitivity
stage cancer overall and by cancer analyses.
type (i.e., Stage III or IV or organ-
specific definition of late stage);
distribution of cancer stage at
diagnosis (i.e., stage shift).
KQ 3: Accuracy (sensitivity, false
negatives, specificity, false
positives, predictive value) by cancer
type and by cancer stage.
KQ 4: Psychosocial and emotional
distress including anxiety and worry,
false reassurance resulting in
decrease in receipt of usual care
screening or change in health
behaviors associated with cancer
(alcohol, tobacco, drug use, diet,
physical activity), overdiagnosis, out-
of-pocket patient costs, patient
financial toxicity, and impact on
insurability.
KQ 5: Radiation exposure from imaging,
harms from invasive procedures, other
adverse effects from evaluation that
occur after a positive MCST, or out-of-
pocket patient costs, patient
financial toxicity, and impact on
insurability.
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Timing
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KQ 1: At least 5 years of followup..... KQ 1: Studies with less than 5
KQs 2, 4, 5: any timing................ years of followup.
KQ 3: At least 1 year of followup for
prediagnostic performance designs.\a\
For diagnostic performance designs,
controls must be considered cancer
free at the time of the sample.
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Setting
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<bullet> Recruitment from outpatient <bullet> Acute care settings,
clinical settings, including primary inpatient care settings.
care or specialty care, community- <bullet> Countries with a
based or public health settings, United Nations Human
electoral rolls, or other population- Development Index of less than
based registries. high.
<bullet> Countries with a United
Nations Human Development Index of
high or very high (Appendix A).
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Study Design
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KQs 1, 2, 4, 5: Randomized controlled For all KQ: Modeling studies,
trials; controlled trials. case series, case reports, in
KQs 1, 2: Registered NRSIs with 1 or vitro lab studies, studies
more eligible benefit outcomes listed designed to assess analytic
on study registration \b\. validity, narrative reviews,
KQs 4, 5: Unregistered NRSIs are also systematic reviews (reviews
eligible. will not be included but will
KQ 3: Studies that provide data related be manually reviewed to
to test accuracy; both prediagnostic identify primary research
test performance and diagnostic test studies that the search may
performance designs are eligible. have missed).
However, only diagnostic performance KQs 1, 2: Cohort studies that
designs conducted in external have not been registered or
validation cohorts are eligible. that report eligible outcomes
Further, if results for multiple that were not included in the
variations of the test are reported by study's registration \b\
authors, only results from the test studies designed with a sample
version selected for future commercial size that was not based on
use or for evaluation in future outcomes related to cancer
intervention studies will be eligible. detection or mortality.
KQ 3: Accuracy results derived
from discovery, development,
internal validation, or split
sample cohorts are not
eligible because multiple
analytes, technologies, or AI
classifiers are being
evaluated to develop the test
and these results do not
reflect the final state of the
test that would be used in
routine practice.
------------------------------------------------------------------------
Language
------------------------------------------------------------------------
English................................ Languages other than English.
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\a\ KQ 3 prediagnostic accuracy performance studies that use disease-
free longitudinal followup as a reference standard should have a
minimum of 1-year followup.
\b\ Refers to study registration in <a href="http://ClinicalTrials.gov">ClinicalTrials.gov</a> database, or
another study registry such as those included in the World Health
Organization International Clinical Trials Registry Platform.
KQ = key question; MCST = multiple cancer screening test; NRSI = non-
randomized study of interventions.
Dated: July 25, 2024.
Marquita Cullom,
Associate Director.
[FR Doc. 2024-16973 Filed 7-31-24; 8:45 am]
BILLING CODE 4160-90-P
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