SERENITY: a case-controlled study of risk factors for developing breast implant associated lymphoma

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12621000546853

Acronym

SERENITY

Enrollment

Registered

2021-05-11

Start date

2021-03-12

Completion date

2021-08-31

Last updated

2021-11-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The SERENITY study will look at demographic and lifestyle factors, and procedural information of patients with breast implants and lymphoma to determine risk factors for breast implant associated lymphoma Who is it for? You may be eligible to join this study if you are aged 18 and above, have had breast implant surgery and/or been diagnosed with lymphoma Study details All participants in this study will self nominate to participate by responding to the advertisements. Participants will then complete an eConsent and then a once-time electronic survey. The demographic, lifestyle and procedural information provided/gathered will be used to determine risk factors for developing breast implant associated lymphoma. It is hoped that the information captured by this study will contribute towards planning for a pilot screening program for BIAL in order to support earlier diagnosis and as such better patient outcomes.

Interventions

non-interventional study. Reviewing the demographics, lifestyle and procedural factors of patients with breast implant, patients with lymphoma, and patients with both Participants will be able to self nominate to complete the survey after seeing the study advertisement. They will complete eConsent and then complete an online survey. Whole process will take max 30 minutes. Participants will not be contacted again Responses are about: Age Sex Gender Ethnicity Private health insurance coverage Breast Implant Surgery Lymphoma diagnosis Alcohol use Diagnosis of high blood pressure Diagnosis of high cholesterol Illicit drug use Diagnosis of iron deficiency Occupational exposures & hazards – exposure to benzene or formaldehyde Other diagnosed medical conditions Overweight & obesity - BMI Tobacco use and exposure Type of implant Age at implant surgery Date of surgery Date of diagnosis of lymphoma Lymphoma subtype Stage at diagnosis Treatment received Lymphoma screening Advised of BIAL risk

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

• 18 or older • Capable of providing consent to participate • Have previously: been diagnosed with lymphoma; or have had breast implant surgery; or have been diagnosed with lymphoma and have also had breast implant surgery. • Live in Australia.

Exclusion criteria

none

Outcome results