Role of Mitochondrial Bioenergetics in Resilience for Gynecologic Cancer

NCT07046936 | Recruiting DMC

• 2 other identifiers: IRB00128756ONC-GYN-2402
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 2

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

Keywords

Mitochondrial Bioenergetics; Cancer

Outcome Measures

Primary Outcomes (4)

• Screening rate

  Proportion of approached patients who signed consent out of the total number of patients who were approached

  Screening

• Enrollment rate

  Proportion of consented participants who initiated at least one pretreatment assessment or had pretreatment blood drawn out of the total number of consented participants

  Screening and pretreatment

• Completion rate

  Proportion of enrolled participants who completed at least one posttreatment assessment (cognitive or physical) out of the total number of enrolled participants

  Pretreatment and up to 30 days following the completion of adjuvant chemotherapy.

• Study Feasibility

  ≥80% enrollment rate, ≥80% completion rate (30 of 37)

  Screening and up to 30 days following the completion of adjuvant chemotherapy

Secondary Outcomes (13)

• Edmonton Symptom Assessment System - Revised (ESAS-r)

  Pretreatment and up to 30 days following the completion of adjuvant chemotherapy

• Short Physical Performance Battery (SPPB)

  Pretreatment and up to 30 days following the completion of adjuvant chemotherapy

• Walking speed

  Pretreatment and up to 30 days following the completion of adjuvant chemotherapy

• Repeated chair stands

  Pretreatment and up to 30 days following the completion of adjuvant chemotherapy

• Standing balance

  Pretreatment and up to 30 days following the completion of adjuvant chemotherapy

Other Outcomes (2)

• Expression of proteins involved in mitochondrial bioenergetic activities in PBMCs

  Pretreatment and up to 30 days following the completion of adjuvant chemotherapy

• Expression of proteins involved in electron transport chain activities in muscle tissue

  Cytoreductive Surgery

Study Arms (1)

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.

Diagnostic Test: muscle sample; Other: blood draw

Interventions

muscle sample DIAGNOSTIC_TEST

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.

Advanced gynecological cancers

blood draw OTHER

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

Advanced gynecological cancers

Eligibility Criteria

• Age: 50 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants with a suspected or confirmed diagnosis of ovarian, primary peritoneal, fallopian tube, or endometrial cancer with planned standard of care treatment.

You may qualify if:

• 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
• Ability to read and understand the English language

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (2)

Atrium Health Levine Cancer

Charlotte, North Carolina, 28204, United States

RECRUITING

Atrium Health Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

PBMCs and muscle biopsies

MeSH Terms

Conditions

Neoplasms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Bumsoo Ahn, PhD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Brandy Baker

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2025
• First Posted: July 2, 2025
• Study Start: March 10, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: April 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)