Ethical Considerations in Endometrial Cancer Research
In the realm of medical research, adhering to ethical principles is paramount. For our comprehensive study on endometrial cancer (EC), we meticulously obtained approvals from various medical ethical committees and governing bodies, ensuring compliance with the Declaration of Helsinki. This unwavering commitment to ethical conduct safeguards the well-being of study participants and fosters trust in our findings.
Informed Consent and Privacy
All participants in our clinical trials provided their explicit informed consent before enrolling in the study. However, for retrospective analyses, we utilized data from existing cohorts, where informed consent was not always feasible. In such instances, ethical boards granted waivers, recognizing the observational nature of these studies and the minimal risk to participants.
For the University Medical Center Groningen (UMCG) cohort, the medical ethical committee granted permission for data use without requiring informed consent due to the observational nature of the study. This decision aligns with ethical guidelines for using existing data for research purposes.
Patient Population and Inclusivity
Our research encompasses a diverse range of cohorts, ensuring a comprehensive representation of the EC patient population. All cohorts included individuals of the female sex, regardless of gender identity. This inclusive approach acknowledges the diversity of the population affected by EC and ensures that our findings are applicable to a broad spectrum of patients.
PORTEC Studies: A Comprehensive Overview of Ethical Considerations and Patient Population
Institutional Approvals: Upholding Ethical Standards
The PORTEC (PORTio cervix and EC) studies have meticulously adhered to stringent ethical guidelines. All protocols received the stamp of approval from the Medical Ethical Committee Leiden, Den Haag, Delft, and other participating centers. The studies’ conduct strictly aligns with the principles enshrined in the Declaration of Helsinki.
Retrospective use of clinical trials and cohorts required ethical permissions, which were diligently obtained from the Medical Ethical Committee Leiden, LUMC, and Danish Cohort’s Center for Regional Udvikling. Informed consent was a cornerstone for clinical trial participants, while other studies received waivers for this requirement. The UMCG cohort’s observational nature granted permission for data use without the need for informed consent.
Patient Population: Focus on Women’s Health
The PORTEC studies were exclusively designed for individuals who identify as female, regardless of gender identity.
Clinical Trial Cohorts
PORTEC-1
* 714 women with early-stage intermediate-risk EC
* Randomized to pelvic external beam radiotherapy or no adjuvant treatment
PORTEC-2
* 427 women with early-stage, high- to intermediate-risk EC
* Randomized to external beam radiotherapy or vaginal brachytherapy
PORTEC-3
* 660 women with stage I-III high-risk EC
* Randomized to pelvic external beam radiotherapy alone or combined with concurrent and adjuvant chemotherapy
TransPORTEC Study
* 116 high-risk EC tumors from international patients
Retrospective Cohorts
MST Cohort
* 257 patients with stage I-III high-risk EC
* Treated at MST, Enschede, Netherlands
Danish Cohort
* 451 patients with high-grade EC
UMCG Cohort
* 278 patients with follow-up data collected until 2010
LUMC Cohort
* 222 patients diagnosed and treated (2012-2021)
TCGA-UCEC Cohort
* Data for 529 patients downloaded from cBioPortal