Clinical trial · Observational
Hydrochlorothiazide and Risk of Skin Cancer
Use of Hydrochlorothiazide and the Risk of Skin Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to determine whether the use of hydrochlorothiazide is associated with an increased risk of skin cancer compared with the use of angiotensin-converting enzyme (ACE) inhibitors. More specifically, the investigators will assess the risk of non-melanoma and melanoma skin cancer. The investigators hypothesize that the use of hydrochlorothiazide is associated with an increased risk of skin cancer compared with ACE inhibitors. The investigators will carry out separate population-based cohort studies using administrative health databases from seven Canadian provinces and the United States. The study cohort will be defined by the initiation of hydrochlorothiazide or an ACE inhibitor, with follow-up until an incident diagnosis of non-melanoma or melanoma skin cancer. The results from the separate sites will be combined to provide an overall assessment of the risk of non-melanoma and melanoma skin cancer in users of hydrochlorothiazide.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hypertension | — | UNRESOLVED | — |
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
| Non-melanoma Skin Cancer | Skin Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Angiotensin-converting enzyme (ACE) inhibitors | Drug | — | UNRESOLVED |
| Hydrochlorothiazide | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Hydrochlorothiazide
- description
- Patients who received a new prescription for hydrochlorothiazide (alone or in combination with non-ACE inhibitor antihypertensive drugs) at cohort entry, and did not have a previous prescription for any antihypertensive drug any time before cohort entry.
- interventionNames
- Drug: Hydrochlorothiazide
- label
- Angiotensin-converting enzyme (ACE) inhibitors
- description
- Patients who received a new prescription for an ACE inhibitor (alone or in combination with non-hydrochlorothiazide antihypertensive drugs) at cohort entry, and did not have a previous prescription for any antihypertensive drug any time before cohort entry.
- interventionNames
- Drug: Angiotensin-converting enzyme (ACE) inhibitors
Primary outcomes (2)
- measure
- Non-melanoma skin cancer
- timeFrame
- Patients will be followed starting 366 days after study cohort entry until an incident diagnosis of non-melanoma skin cancer, censoring or for up to 275 months, whichever occurs first.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria: * Patients aged 40 years or older (or 66 years or older in Alberta, Nova Scotia and Ontario) newly-treated with hydrochlorothiazide or an ACE inhibitor between April 1, 1995 and March 31, 2018 (or the latest date of data availability at each site) Exclusion Criteria: * Patients with less than one year of health coverage before cohort entry * Patients with a previous prescription of any antihypertensive drug at any time before cohort entry * Patients with a diagnosis of any type of skin cancer (non-melanoma and melanoma) at any time before cohort entry * Patients with a diagnosis of HIV at any time before cohort entry * Patients with a history of solid organ transplant at any time before cohort entry * Patients with less than one year of follow-up after cohort entry
References
Publications (2)
- BACKGROUNDChan AW, Fung K, Tran JM, Kitchen J, Austin PC, Weinstock MA, Rochon PA. Application of Recursive Partitioning to Derive and Validate a Claims-Based Algorithm for Identifying Keratinocyte Carcinoma (Nonmelanoma Skin Cancer). JAMA Dermatol. 2016 Oct 1;152(10):1122-1127. doi: 10.1001/jamadermatol.2016.2609. PMID 27533718
- RESULTAzoulay L, St-Jean A, Dahl M, Quail J, Aibibula W, Brophy JM, Chan AW, Bresee L, Carney G, Eltonsy S, Tamim H, Paterson JM, Platt RW; Canadian Network for Observational Drug Effect Studies (CNODES) Investigators. Hydrochlorothiazide use and risk of keratinocyte carcinoma and melanoma: A multisite population-based cohort study. J Am Acad Dermatol. 2023 Aug;89(2):243-253. doi: 10.1016/j.jaad.2023.04.035. Epub 2023 Apr 25. PMID 37105517