Revealing Engagement Patterns Among Endometrial Cancer Patients

Endometrial Cancer Clinical Trial

Official title:

A Journey Endometrial Cancer Clinical Trials - Revealing Engagement Patterns Among Individuals Affected by Endometrial Cancer

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05998798
• Other study ID #: 82379206
• Status: Not yet recruiting
• Start date: September 2024
• Est. completion date: September 2026

Study information

• Verified date: August 2023
• Source: Power Life Sciences Inc.
• Contact: Michael B Gill
• Phone: (415) 900-4227
• Email: bask[@]withpower.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The study intends to investigate the personal experiences of endometrial cancer patients who take part in a separate clinical study including a specific medication intervention. The major focus will be on closely following individuals' rates of trial completion and withdrawal.

The data collected from this study will help improve future outcomes for all endometrial cancer patients as well as those in under-represented demographic groups.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: September 2026
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients diagnosed with endometrial cancer

• Aged = 18 years old and ability to provide written informed consent obtained prior to participation in the study and any related procedures being performed

• Subjects willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examination.

Exclusion Criteria:

• Refusal of consent

• Women of childbearing potential without a negative pregnancy test; or women who are lactating.

• Any serious and/or unstable pre-existing medical disorders

Related Conditions & MeSH terms

• Endometrial Cancer
• Endometrial Neoplasms

Locations

Country	Name	City	State
United States	Power Life Sciences	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Power Life Sciences Inc.

Country where clinical trial is conducted

United States, 

References & Publications (3)

Marth C, Tarnawski R, Tyulyandina A, Pignata S, Gilbert L, Kaen D, Rubio MJ, Frentzas S, Beiner M, Magallanes-Maciel M, Farrelly L, Choi CH, Berger R, Lee C, Vulsteke C, Hasegawa K, Braicu EI, Wu X, McKenzie J, Lee JJ, Makker V. Phase 3, randomized, open-label study of pembrolizumab plus lenvatinib versus chemotherapy for first-line treatment of advanced or recurrent endometrial cancer: ENGOT-en9/LEAP-001. Int J Gynecol Cancer. 2022 Jan;32(1):93-100. doi: 10.1136/ijgc-2021-003017. Epub 2021 Nov 19. — View Citation

O'Malley DM, Bariani GM, Cassier PA, Marabelle A, Hansen AR, De Jesus Acosta A, Miller WH Jr, Safra T, Italiano A, Mileshkin L, Xu L, Jin F, Norwood K, Maio M. Pembrolizumab in Patients With Microsatellite Instability-High Advanced Endometrial Cancer: Results From the KEYNOTE-158 Study. J Clin Oncol. 2022 Mar 1;40(7):752-761. doi: 10.1200/JCO.21.01874. Epub 2022 Jan 6. — View Citation

Stelloo E, Nout RA, Osse EM, Jurgenliemk-Schulz IJ, Jobsen JJ, Lutgens LC, van der Steen-Banasik EM, Nijman HW, Putter H, Bosse T, Creutzberg CL, Smit VT. Improved Risk Assessment by Integrating Molecular and Clinicopathological Factors in Early-stage Endometrial Cancer-Combined Analysis of the PORTEC Cohorts. Clin Cancer Res. 2016 Aug 15;22(16):4215-24. doi: 10.1158/1078-0432.CCR-15-2878. Epub 2016 Mar 22. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients who decide to enroll in an endometrial cancer clinical research		3 months
Primary	Rate of patients who remain in an endometrial cancer clinical trial to trial completion		12 months