Notice2023-19031
Supplemental Evidence and Data Request on Treatment of Stage I-III Squamous Cell Anal Cancer
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
September 5, 2023
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 Treatment of Stage I-III Squamous Cell Anal Cancer, 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 Access to published and unpublished pertinent scientific information will improve the quality of this review.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 88 Issue 170 (Tuesday, September 5, 2023)</title>
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[Federal Register Volume 88, Number 170 (Tuesday, September 5, 2023)]
[Notices]
[Pages 60681-60683]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-19031]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality
Supplemental Evidence and Data Request on Treatment of Stage I-
III Squamous Cell Anal Cancer
AGENCY: Agency for Healthcare Research and Quality (AHRQ), HHS.
ACTION: Request for supplemental evidence and data submissions.
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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 Treatment of
Stage I-III Squamous Cell Anal Cancer, 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Access to published and unpublished pertinent scientific information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 October 5, 2023.
ADDRESSES:
Email submissions: <a href="/cdn-cgi/l/email-protection#3e5b4e5d7e5f564c4f1056564d10595148"><span class="__cf_email__" data-cfemail="0c697c6f4c6d647e7d2264647f226b637a">[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#6a0f1a092a0b02181b44020219440d051c"><span class="__cf_email__" data-cfemail="6207120122030a10134c0a0a114c050d14">[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 Treatment of Stage I-
III Squamous Cell Anal Cancer. 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 Treatment of Stage I-III Squamous Cell Anal Cancer. The
entire research protocol is available online at: <a href="https://effectivehealthcare.ahrq.gov/products/anal-cancer-treatment/protocol">https://effectivehealthcare.ahrq.gov/products/anal-cancer-treatment/protocol</a>.
This is to notify the public that the EPC Program would find the
following information on Treatment of Stage I-III Squamous Cell Anal
Cancer 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://www.effectivehealthcare.ahrq.gov/email-updates">https://www.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 are the effectiveness and harms of different modalities
of initial treatment for stages I-III squamous cell anal cancer?
KQ 2. What are the effectiveness and harms of different modalities
of radiation therapy for initial treatment of stages I-III squamous
cell anal cancer?
KQ 3. What are the effectiveness and harms of different radiation
therapy doses, volumes, and fractionation schema for initial treatment
of stage I-III squamous cell anal cancer?
KQ 4. What are the effectiveness and harms of different
combinations of chemotherapy and radiation therapy, and dose de-
escalation or dose escalation for initial treatment of stages I-III
squamous cell anal cancer?
KQ 5. What are the effectiveness and harms of immunotherapy for
initial treatment of stages I-III squamous cell anal cancer?
KQ 6. What are the effectiveness and harms of different frequencies
and modalities for post-treatment surveillance strategies after initial
treatment of stages I-III squamous cell anal cancer?
For all KQs, do the outcomes differ by patient characteristics such
as age, sex, immunocompromised status, or other characteristics
associated with health inequities (such as race/ethnicity)?
[[Page 60682]]
PICOTS (Populations, Interventions, Comparators, Outcomes, Timing, and Setting)
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Inclusion Exclusion
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Population:
All KQ......................... Adults with stages I-III squamous cell Adults with:
anal cancer (anal canal and anal margin). <bullet> Stage IV anal cancer.
<bullet> Lower rectal cancer
that has spread to the anal
canal.
<bullet> Non-squamous cell anal
cancer (e.g., adenocarcinomas,
undifferentiated cancer).
Patient characteristics such as age, sex,
immunocompromised status, or other
characteristics associated with health
inequities (such as race/ethnicity).
.......................................... Studies including mixed
populations with Stages I-IV
squamous cell anal cancer
which contain 20% or greater
proportion of stage IV
squamous cell anal cancer.
Interventions:
KQ1............................ Alone or in combination as neoadjuvant/ <bullet> Reconstructive
adjuvant or as induction/maintenance:. surgery.
<bullet> Surgery, radiation therapy, or <bullet> Palliative therapy
chemotherapy. (includes chemotherapy with
palliative intent).
<bullet> Treatment for
premalignant lesions.
KQ2............................ Different modalities of radiation therapy <bullet> Palliative therapy.
such as, but not limited to, IMRT, proton
radiation therapy, and Brachytherapy
boost.
KQ3............................ Radiation therapy; varying:............... <bullet> Palliative therapy.
<bullet> Doses............................
<bullet> Target (primary and nodal)
volumes.
<bullet> Fractionation schema.............
KQ4............................ <bullet> Chemotherapy and radiation <bullet> Palliative therapy.
therapy combinations (e.g., 5-
Fluorouracil, Mitomycin-C, Cisplatin).
<bullet> Variations in dose of:...........
[cir] Radiation therapy...................
[cir] Chemotherapy........................
KQ5............................ Immunotherapy (e.g., pembrolizumab,
nivolumab).
KQ6............................ Post-treatment surveillance strategies:... <bullet> Screening for primary
prevention.
<bullet> Frequency........................
<bullet> Modalities (e.g., MRI, PET scans, <bullet> Initial staging.
biopsy, DRE, anoscopy, flexible
sigmoidoscopy).
<bullet> Strategies for surveillance post
non-initial treatment.
Comparison:
KQ1............................ Alone or in combination as neoadjuvant/ <bullet> Reconstructive
adjuvant or as induction/maintenance:. surgery.
<bullet> Palliative therapy
(includes chemotherapy with
palliative intent).
<bullet> Surgery, radiation therapy, or <bullet> Treatment for
chemotherapy. premalignant lesions.
KQ2............................ Comparators for different modalities of <bullet> Palliative therapy.
radiation therapy such as, but not
limited to, 3-D CRT, photon or electron
radiation therapy, and external beam
radiation therapy boost.
KQ3............................ Radiation therapy; varying:............... <bullet> Palliative therapy.
<bullet> Doses............................
<bullet> Target (primary and nodal)
volumes.
<bullet> Fractionation schema.............
KQ4............................ <bullet> Chemotherapy and radiation <bullet> Palliative therapy.
therapy combinations (e.g., 5-
Fluorouracil, Mitomycin-C, Cisplatin).
<bullet> Variations in dose...............
[cir] Radiation therapy...................
[cir] Chemotherapy........................
KQ5:........................... Other treatment (e.g., chemotherapy, ...............................
radiation therapy, chemotherapy +
radiation therapy).
KQ6............................ Post-treatment surveillance strategies:... <bullet> Screening for primary
prevention.
<bullet> Initial staging.
<bullet> Strategies for
surveillance post non-initial
treatment.
<bullet> Frequency........................
<bullet> Modalities (e.g., MRI, PET scans,
biopsy, DRE, anoscopy, flexible
sigmoidoscopy).
Outcomes:
All KQ......................... <bullet> Overall survival.................
<bullet> Disease specific survival........
<bullet> Disease-free survival (including
persistence, recurrence, or relapse).
<bullet> Colostomy-free survival..........
<bullet> Local control....................
<bullet> Complete clinical response.......
<bullet> Salvage rate.....................
<bullet> Sphincter preservation...........
<bullet> Health-related quality of life...
[[Page 60683]]
<bullet> Treatment breaks (frequency or
duration), treatment discontinuation,
interruptions, or median treatment days.
<bullet> Bleeding per rectum..............
<bullet> Functional outcomes (e.g., fecal
or urinary incontinence, erectile
dysfunction, sexual dysfunction, use of
vaginal dilators).
<bullet> Harms of treatment including
acute and late toxicity (e.g.,
myelosuppression, gastrointestinal
toxicity, such as diarrhea, vomiting, and
bowel obstruction, secondary malignancy,
radiation dermatitis, radiation
proctitis, radiation cystitis, pelvic
insufficiency fractures, vaginal
stenosis).
Timing:
All KQ......................... No restrictions on duration of treatments
or follow-up.
Setting:
All KQ......................... Cancer care settings......................
Study design:
All KQ......................... Randomized controlled trials, non- Case reports, case series,
randomized controlled trials, commentaries, cross-sectional
observational cohort with concurrent studies, reviews, qualitative
comparator, interrupted time-series, and studies, studies with sample
other quasi-experimental designs using size less than 30 patients (or
appropriate analytic techniques. less than 15 per treatment
group/arm), non-randomized
studies with unspecified or
poorly defined intervention/
treatment protocol (e.g., lack
of names of chemotherapy
agents used), non-randomized
studies with analytic
techniques that don't allow
drawing causal inferences.
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Abbreviations: 3-D CRT= three-dimensional conformal radiation therapy; DRE= digital rectal exam; IMRT=intensity-
modulated radiation therapy; KQ=key question; MRI= magnetic resonance imaging; PET= positron emission
tomography; RCT=randomized controlled trial; VMAT= Volumetric modulated arc therapy.
Marquita Cullom,
Associate Director.
[FR Doc. 2023-19031 Filed 9-1-23; 8:45 am]
BILLING CODE 4160-90-P
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