Comparative risk of the incident cancer between histamine-2 receptor antagonists (Risk of cancer between H2RAs)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/42946
• EU PAS number:
  EUPAS38902
• Study ID:
  42946
• Official title and acronym:
  Comparative risk of the incident cancer between histamine-2 receptor antagonists (Risk of cancer between H2RAs)
• DARWIN EU® study:
  No
• Study countries:
  France

  Germany

  Korea, Republic of

  Spain

  United Kingdom

  United States
• Study description:
  Dietary N-nitrosodimethylamine (NDMA) has been shown to be carcinogenic in animals, however, evidence from population-based studies is inconlusive. The U.S. Food and Drug Administration has issued a statement on ranitidine because they may contain unacceptable levels of NDMA in 2019. To date, there have been several studies regarding association between NDMA exposure and risk of cancer, however, real-world evidence of cancer risk in relation with ranitidine is scarce. We aim to evaluate the comparative risk of incident cancer in patients exposed to various H2 receptor antagonists (H2RAs). We will conduct systematic, multinational study to estimate the relative risk of primary outcome (overall cancer except non-melanoma skin cancer) and secondary outcomes (overall cancer, overall cancer except thyroid cancer, 16 types of cancer, and cancer mortality) in ranitidine cohort. We will compare the target cohort with the comparator cohort for the hazards of outcome during the time-at-risk by applying a Cox proportional hazards model after propensity score adjustment.
• Study status:
  Planned

Research institution and networks

Institutions

Yonsei University

IQVIA

United Kingdom

Ajou University

IQVIA

United Kingdom

NHIS South Korea, Hanyang University South Korea, Ajou University South Korea, Kangdong Sacred Heart Hospital South Korea, Columbia University US, Stanford University US, IQVIA US

Study timelines

Date when funding contract was signed

Planned: 01/01/2021

Study start date

Planned: 18/01/2021

Date of final study report

Planned: 01/11/2021

Sources of funding

Other

More details on funding

Ministry of Health & Welfare, Republic of Korea. grant number: HI19C0143

Study protocol

Initial protocol

H2RACancerRisk_Protocol_V0.5

Updated protocol

H2RACancerRisk_Protocol_V0.5.1

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Non-EU RMP only

Other study registration identification numbers and links

https://github.com/ohdsi-studies/ranitidinecancerrisk