Notice2024-19344
Supplemental Evidence and Data Request on Medical Therapies for Locally Advanced Gastric Adenocarcinoma
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 28, 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 Medical Therapies for Locally Advanced Gastric Adenocarcinoma, 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 Access to published and unpublished pertinent scientific information will improve the quality of this review.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 167 (Wednesday, August 28, 2024)</title>
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[Federal Register Volume 89, Number 167 (Wednesday, August 28, 2024)]
[Notices]
[Pages 68904-68906]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-19344]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality
Supplemental Evidence and Data Request on Medical Therapies for
Locally Advanced Gastric Adenocarcinoma
AGENCY: Agency for Healthcare Research and Quality (AHRQ), HHS. ACTION:
Request for Supplemental Evidence and Data Submission 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 Medical Therapies for Locally
Advanced Gastric Adenocarcinoma, 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published and unpublished pertinent scientific information will improve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 27, 2024.
ADDRESSES:
Email submissions: <a href="/cdn-cgi/l/email-protection#2d485d4e6d4c455f5c0345455e034a425b"><span class="__cf_email__" data-cfemail="f2978291b2939a8083dc9a9a81dc959d84">[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#d8bda8bb98b9b0aaa9f6b0b0abf6bfb7ae"><span class="__cf_email__" data-cfemail="afcadfccefcec7ddde81c7c7dc81c8c0d9">[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 Medical Therapies for
Locally Advanced Gastric Adenocarcinoma. 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 Medical Therapies for Locally Advanced Gastric
Adenocarcinoma. The entire research protocol is available online at:
<a href="https://effectivehealthcare.ahrq.gov/products/gastric-cancers/protocol">https://effectivehealthcare.ahrq.gov/products/gastric-cancers/protocol</a>.
This is to notify the public that the EPC Program would find the
following information on Medical Therapies for Locally Advanced Gastric
Adenocarcinoma 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
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)
KQ1: What is the comparative effectiveness and comparative harms of
medical therapies for management of non-metastatic, locally advanced
gastric adenocarcinoma?
KQ2: Do treatment effectiveness and harms vary by cancer stage,
histology (e.g. intestinal, diffuse, signet ring cell), biomarkers
(e.g. microsatellite instability-high [MSI-H] or mismatch repair-
deficient [MMR-deficient], claudin, human epidermal growth factor
receptor 2 [HER-2], programmed death-ligand 1 [PDL1], Epstein-Barr
virus [EBV]), or genetic predisposition (e.g. cadherin-1 [CDH1])?
[[Page 68905]]
KQ3: Do treatment effectiveness and harms vary by age, functional
status (e.g. Karnofsky score, Eastern Cooperative Oncology Group [ECOG]
Performance Status score), medical comorbidities or conditions that
increase risk of toxicity with specific therapy (e.g. existing
neuropathy, prior radiation therapy, history of autoimmune disease)?
PICOTS (Population, Interventions, Comparators, Outcomes, Timing, and Setting)
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PICOTS Inclusion Exclusion
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Population......................... All KQs:............................. Recurrent cancer, metastatic cancer,
Adults (18 years or older) with early stage (T1aN0 and T1bN0),
primary, non-recurrent, non- stage 4 cancer, GEJ cancer patients
metastatic locally advanced gastric treated in a predominantly
adenocarcinoma stage T2N0 or higher. esophageal cancer cohort with an
KQ1: Subgroups of interest may esophageal treatment paradigm,
include patients who previously gastrointestinal stromal tumors
received endoscopic therapy or (GIST), neuroendocrine tumors,
surgery, patients who are non- gastric lymphoma, MALToma, other
surgical candidates, and patients rare gastric cancers.
with initially unresectable disease.
KQ2: Subgroups of interest may
include patients with
gastroesophageal junction (GEJ)
cancer.
Interventions...................... All KQs..............................
Cancer-directed medical therapies <bullet> Surgical management
administered either alone or in any exclusively.
combination, and may be neoadjuvant, <bullet> Intervention is not well
adjuvant, or perioperative specified (e.g., study reports
(neoadjuvant and adjuvant) and in intervention as ``adjuvant
any sequence:. chemotherapy'' without describing
<bullet> Chemotherapy including but the regimen).
not limited to: Fluoropyrimidine- <bullet> Palliative interventions.
based therapy: FOLFOX, XELOX, FLOT,
SOX, ECF.
<bullet> Radiation including but not
limited to external beam radiation,
intra-operative electron radiation.
<bullet> Chemoradiation..............
<bullet> HIPEC.......................
<bullet> Immunotherapy (e.g.,
ipilimumab, nivolimumab).
<bullet> Targeted therapy (e.g., anti-
HER2 monoclonal antibodies).
Comparators........................ All KQs.............................. N/A.
<bullet> Any comparator..............
<bullet> No comparator (for biomarker-
targeted interventions).
Outcomes........................... All KQs.............................. N/A.
<bullet> Overall survival............
<bullet> Progression-free survival...
<bullet> Nutritional assessment......
<bullet> Quality of life, using
validated scales.
<bullet> Direct moderate-severe
treatment adverse events (grade 3,
4, 5).
<bullet> Direct mild treatment
adverse events (grade 1, 2).
<bullet> Indirect adverse events from
treatment (e.g., long-term opioid
use for pain management).
Timing............................. All KQs:............................. N/A.
Any follow-up duration for grade 3-5
or indirect adverse events and
quality of life; minimum of 1 year
for grade 1-2 adverse events;
minimum of 3 months for remaining
outcomes.
Setting............................ All KQs:............................. N/A.
<bullet> Countries rated as very high
on the 2024 Human Development Index
(if study is multinational, at least
one study center is in a country
rated very high).
Study Design and Other Criteria.... All KQs:............................. Case reports, case series,
<bullet> Randomized controlled trials commentaries, cross-sectional
<bullet> Non-randomized studies of studies, reviews, qualitative
interventions (experimental or studies.
observational) with a concurrent
comparator and well-controlled for
confounding (at minimum account for
age, stage, functional status, and
comorbidities).
<bullet> Single-arm studies (for
biomarker-targeted interventions).
<bullet> Published in English-
language.
<bullet> Published in 2006 or later..
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[[Page 68906]]
Abbreviations: ECF = epirubicin, cisplatin, fluorouracil; FLOT =
fluorouracil, leucovorin, oxaliplatin and docetaxel; FOLFOX =
leucovorin, fluorouracil, and oxaliplatin; HER2 = human epidermal
growth factor receptor 2; HIPEC = hyperthermic intraperitoneal
chemotherapy; KQ = key question; SOX = tegafur, gimeracil, oteracil,
and oxaliplatin; XELOX = capecitabine and oxaliplatin.
Marquita Cullom,
Associate Director.
[FR Doc. 2024-19344 Filed 8-27-24; 8:45 am]
BILLING CODE 4160-90-P
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