Recruiting

Observational Study

Sponsor:

Wake Forest University Health Sciences

Code:

NCT07046936

Conditions

Gynecologycal Cancer

Eligibility Criteria

Sex: Female

Age: 50+

Healthy Volunteers: Not accepted

Interventions

muscle sample

blood draw

Study Details

Brief summary:

The purpose of this research study is to see if patients with endometrial and ovarian cancer are willing to complete physical and cognitive assessments before treatment and again after treatment has ended.

Conditions

Gynecologycal Cancer

Study ID

NCT07046936

Start date

Mar 10, 2026

Status verified date

Jul, 2026

Completion date

Apr, 2027

Anticipated

Primary completion date

Apr, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 50+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Ability to understand and willingness to sign an IRB-approved informed consent
  • Age ≥50 years at the time of enrollment
  • Newly diagnosed or suspected FIGO Stage II-IV ovarian/primary peritoneal/fallopian tube carcinoma of any histological subtype OR FIGO Stage II-IV endometrial carcinoma of any histological subtype
  • Planned, standard of care treatment consisting of neoadjuvant chemotherapy, tumor reduction surgery, and adjuvant chemotherapy OR tumor reduction surgery with adjuvant chemotherapy
  • Ability to read and understand the English language

Exclusion Criteria:

  • Previously treated for ovarian or endometrial cancer
  • History of brain metastases, whole brain irradiation, poorly controlled psychiatric disorders defined by hospitalization within the last 3 months for psychiatric diagnoses, traumatic brain injury, cerebrovascular event, or dementia
  • Currently taking anti-amyloid agents, cholinesterase inhibitors, or glutamate regulator
  • Documented physical or psychological comorbidity that would limit participant's ability to understand or comply with study procedures for the entire length of the study

Study Design

Enrollment

30 participants

Anticipated

Interventions and Outcome Measures

Arms

Advanced gynecological cancers

Participants 50 years and older with suspected or newly diagnosed advanced gynecological cancer (ovarian/primary peritoneal/fallopian tube or endometrial carcinoma of any histological subtype) who are planned to undergo SOC treatment.

Interventions

muscle sample

For participants undergoing standard of care interval cytoreductive surgery via laparotomy, a skeletal muscle biopsy from the rectus abdominis muscle (1 cm x 1 cm x 1 cm, \~300 mg) will be collected.

For participants who undergo standard of care interval cytoreductive surgery with a laparoscopic approach, a skeletal muscle biopsy will be taken from either the rectus abdominis (1 cm x 1 cm x 1 cm, \~300 mg) or the psoas (1 cm x 0.5 cm x 0.5 cm, \~200 mg) muscle.

blood draw

A total of approximately 60mL or 4 tablespoons of blood will be collected throughout the study

Primary outcome measure

  • Screening rate [ Time Frame: Screening ]
  • Enrollment rate [ Time Frame: Screening and pretreatment ]
  • Completion rate [ Time Frame: Pretreatment and up to 30 days following the completion of adjuvant chemotherapy. ]
  • Study Feasibility [ Time Frame: Screening and up to 30 days following the completion of adjuvant chemotherapy ]

Central Contacts and Locations

Central contacts

Brandy Baker

(336) 713-8941brandy.baker@advocatehealth.org

Locations

Atrium Health Levine Cancer

Recruiting

Charlotte, North Carolina, United States, 28204

Contacts

Brittany Lees, MD

704-355-2000Brittany.lees@advocatehealth.org

Principal Investigator:

Brittany Lees, MD

Atrium Health Wake Forest Baptist Comprehensive Cancer Center

Recruiting

Winston-Salem, North Carolina, United States, 27157

Contacts

Brandy Baker

(336) 713-0031jwyche@wakehealth.edu

Principal Investigator:

Bumsoo Ahn, PhD

More Information

Sponsor

Wake Forest University Health Sciences

Last update posted

Jul 30, 2026

Last verified

Jul, 2026

Keywords

  • Mitochondrial Bioenergetics
  • Cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Wake Forest University Health Sciences on 2026-07-30.