Final Research Plan

Pancreatic Cancer: Screening

August 17, 2017

Recommendations made by the USPSTF are independent of the U.S. government. They should not be construed as an official position of the Agency for Healthcare Research and Quality or the U.S. Department of Health and Human Services.

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The final Research Plan is used to guide a systematic review of the evidence by researchers at an Evidence-based Practice Center. The resulting Evidence Review will form the basis of the USPSTF Recommendation Statement on this topic.

The draft Research Plan was available for comment from April 27 to May 24, 2017.

 

The analytic framework depicts the five Key Questions (KQs) described in the research plan. Specifically, it illustrates the following questions: whether screening for pancreatic adenocarcinoma improves cancer morbidity or mortality or all-cause mortality (KQ1); whether screening effectiveness varies by clinically relevant subpopulations, such as by age group, family history of pancreatic cancer, personal history of new-onset diabetes, or other risk factors (KQ1a); the diagnostic accuracy of screening tests for pancreatic adenocarcinoma (KQ2); the harms of screening for pancreatic adenocarcinoma (KQ3); whether treatment of screen-detected or asymptomatic pancreatic adenocarcinoma improves cancer mortality, all-cause mortality, or quality of life (KQ4); and the harms of treatment of screen-detected pancreatic adenocarcinoma (KQ5).

Abbreviation: KQ=key question.

Text Description

The analytic framework depicts the five Key Questions (KQs) described in the research plan. Specifically, it illustrates the following questions: whether screening for pancreatic adenocarcinoma improves cancer morbidity or mortality or all-cause mortality (KQ1); whether screening effectiveness varies by clinically relevant subpopulations, such as by age group, family history of pancreatic cancer, personal history of new-onset diabetes, or other risk factors (KQ1a); the diagnostic accuracy of screening tests for pancreatic adenocarcinoma (KQ2); the harms of screening for pancreatic adenocarcinoma (KQ3); whether treatment of screen-detected or asymptomatic pancreatic adenocarcinoma improves cancer mortality, all-cause mortality, or quality of life (KQ4); and the harms of treatment of screen-detected pancreatic adenocarcinoma (KQ5).

  1. Does screening for pancreatic adenocarcinoma improve cancer morbidity or mortality or all-cause mortality?
    1. Does screening effectiveness vary by clinically relevant subpopulations (e.g., by age group, family history of pancreatic cancer, personal history of new-onset diabetes, or other risk factors)?
  2. What is the diagnostic accuracy of screening tests for pancreatic adenocarcinoma?
  3. What are the harms of screening for pancreatic adenocarcinoma?
  4. Does treatment of screen-detected or asymptomatic pancreatic adenocarcinoma improve cancer mortality, all-cause mortality, or quality of life?
  5. What are the harms of treatment of screen-detected pancreatic adenocarcinoma?

Contextual questions will not be systematically reviewed and are not shown in the Analytic Framework.

  1. What tools are available for assessing risk of pancreatic adenocarcinoma in primary care?
  2. What is the natural history and prognosis of early- vs. late-stage pancreatic adenocarcinoma?
  3. What is the role of biomarkers or multiple-biomarker panels in screening for pancreatic adenocarcinoma?

The Research Approach identifies the study characteristics and criteria that the Evidence-based Practice Center will use to search for publications and to determine whether identified studies should be included or excluded from the Evidence Review. Criteria are overarching as well as specific to each of the key questions (KQs).

  Included Excluded
Population KQs 1–3: Adults age ≥18 years, with or without risk factors for pancreatic adenocarcinoma (e.g., family history of pancreatic cancer, personal history of new-onset diabetes, or other risk factors)*
KQs 4, 5: Adults with screen-detected or asymptomatic pancreatic adenocarcinoma		 KQs 1–3:
  • Children and adolescents
  • Persons with history of pancreatic cancer
  • Studies focusing only on persons with a known genetic syndrome associated with increased risk for pancreatic cancer (e.g., Peutz-Jeghers syndrome, Lynch syndrome, hereditary pancreatitis, known mutations in CDKN2A, BRCA1, BRCA2, CTFR, or ATM genes)†
KQs 4, 5: Symptomatic populations with pancreatic adenocarcinoma; populations with pancreatic endocrine or exocrine tumors other than adenocarcinoma
Setting Studies conducted in countries categorized as "Very High" on the 2016 Human Development Index (as defined by the United Nations Development Programme)  
Screening test Any imaging-based screening protocol, including but not limited to: computed tomography scan, endoscopic ultrasonography, magnetic resonance imaging, and abdominal ultrasonography Serum, stool, or saliva-based testing for biomarkers, such as cancer antigen 19-9, carcinoembryonic antigen, cell-surface proteins, micro-RNA, hypermethylation of specific genes in circulating DNA, circulating tumor cells, or multiple-biomarker panels
Treatment KQs 4, 5: Surgical resection, with or without chemotherapy or radiation therapy Chemotherapy or palliative care alone
Comparisons KQ 1: No screening
KQ 2: Reference standard (e.g., clinical followup)
KQ 4: No treatment or delayed treatment		 Comparative effectiveness screening or treatment studies
Outcomes KQs 1, 4: Reduced pancreatic adenocarcinoma morbidity or mortality, reduced all-cause mortality, and improved quality of life
KQ 2: Sensitivity, specificity, positive predictive value, and lesion detection rate
KQs 3, 5: Any harm from screening or treatment, including false-positive or false-negative results, serious psychological harms, or treatment-related adverse events		 KQ 3: Incidentally identified lesions
Study design All KQs: Fair- or good-quality studies (according to design-specific USPSTF criteria) published from 2002 to the present‡
KQ 1: Randomized, controlled trials; controlled clinical trials
KQ 2: Diagnostic accuracy studies with a reference standard; systematic evidence reviews
KQs 3, 5: Randomized, controlled trials; controlled clinical trials; cohort studies; case-control studies
KQ 4: Randomized, controlled trials; controlled clinical trials; cohort studies		 Poor-quality studies with a fatal flaw; studies occurring outside of the specified publication dates; case reports and case series; narrative reviews, commentaries, editorials, theses, qualitative studies, ecologic studies, comparative effectiveness studies, and decision analyses; studies not available in the English language

*Results will be stratified by risk factors, such as age, sex, or clinical characteristics, where possible.
†Studies consisting entirely of populations with high-risk genetic syndromes will be excluded, but studies that include persons with high-risk genetic syndromes in addition to persons with other risk factors will not be excluded.
‡Studies included in the previous USPSTF review (search dates through December 2001) that meet current inclusion criteria will be included.

Abbreviations: DNA=deoxyribonucleic acid; RNA=ribonucleic acid.

A draft version of this research plan was posted for public comment on the USPSTF Web site from April 27 through May 24, 2017. As a result of public comment, the USPSTF made several clarifications to the language in the inclusion and exclusion criteria, including expanding the list of potential clinically relevant risk factors (also depicted in the analytic framework), revising language on the exclusion of study populations entirely comprised of persons with known genetic syndromes, and adding "included but not limited to" in the section on included screening tests. The USPSTF made no changes to the key questions, contextual questions, or research approach.