Recruiting

Observational Study

Sponsor:

UCLA

Code:

NCT06089083

Conditions

Malignant Female Reproductive System Neoplasm

Gynecologic Cancer

Gynecologic Neoplasm

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Physical function assessment

Self-reported Assessments and Questionnaires

Surgery (Standard of Care, Non-Interventional)

Study Details

Brief summary:

This study seeks to understand how frailty, a term that describes people who are more vulnerable stressors such as a new medical problem, affects the outcomes and quality of life in adult patients with gynecologic cancer.

Conditions

Malignant Female Reproductive System Neoplasm

Gynecologic Cancer

Gynecologic Neoplasm

Study ID

NCT06089083

Start date

Oct 18, 2023

Status verified date

Jan, 2026

Completion date

Nov 30, 2033

Anticipated

Primary completion date

Nov 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age 18 years or greater
  • Undergoing evaluation for a newly diagnosed gynecologic malignancy
  • Ability of individual or legal guardian/representative to understand a written informed consent document, and the willingness to sign it

Exclusion Criteria:

  • Contraindication to any study-related procedure or assessment
  • Does not speak a language for which the consent form and study materials are available

Study Design

Enrollment

500 participants

Anticipated

Interventions and Outcome Measures

Arms

Newly diagnosed gynecologic cancer

Participants will undergo physical function assessments, complete surveys, and medical records every 3 months +/- 4 weeks prior to standard of care surgery (outside of this protocol). After surgery subjects will be followed for at least 3 months +/- 4 weeks for up to one year after diagnosis. Medical record reviews will occur periodically to examine for long-term follow up oncologic outcomes of progression free survival, overall survival, and chemotherapy delays for up to 10 years after enrollment.

Interventions

Physical function assessment

Physical assessments of frailty will be conducted in person.

Self-reported Assessments and Questionnaires

Quality of life questionnaires and self-reported measures will be provided to complete during the course of the study

Surgery (Standard of Care, Non-Interventional)

Surgical data will be reviewed via medical record

Primary outcome measure

  • Proportion of participants who are categorized as frail [ Time Frame: At time of enrollment, 1 day ]
  • Demographic risk factors associated with those who screen positive for frailty [ Time Frame: At time of enrollment, 1 day ]
  • Oncologic risk factors associated with those who screen positive for frailty [ Time Frame: At time of enrollment, 1 day ]

Central Contacts and Locations

Central contacts

Janet Titzler

415-353-9600janet.titzler@ucsf.edu

Locations

University of California, San Francisco

Recruiting

San Francisco, California, United States, 94143

Contacts

Janet Titzler

415-353-9600Janet.Titzler@ucsf.edu

877-827-3222cancertrials@ucsf.edu

Principal Investigator:

Stephanie Cham, MD

Dana Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Alexi Wright, MD, MPH

617-632-2334Alexi_Wright@dfci.harvard.edu

Principal Investigator:

Alexi Wright, MD MPH

More Information

Sponsor

University of California, San Francisco

Last update posted

Jan 26, 2026

Last verified

Jan, 2026

Keywords

  • Frailty
  • Risk Factors

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Francisco on 2026-01-26.