Role of Mitochondrial Bioenergetics in Resilience for Gynecologic Cancer
NCT ID: NCT07046936
Last Updated: 2025-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
30 participants
OBSERVATIONAL
2026-02-28
2027-04-30
Brief Summary
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Detailed Description
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In addition, blood and muscle tissues will be collected at baseline and at the time of surgery, respectively for correlative studies to measure mitochondrial respiration.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
50 Years
FEMALE
No
Sponsors
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Wake Forest University Health Sciences
OTHER
Responsible Party
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Principal Investigators
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Bumsoo Ahn, PhD
Role: PRINCIPAL_INVESTIGATOR
Wake Forest University Health Sciences
Locations
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Atrium Health Levine Cancer
Charlotte, North Carolina, United States
Atrium Health Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina, United States
Countries
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Central Contacts
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Facility Contacts
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Brittany Lees, MD
Role: primary
Brandy Baker
Role: primary
Other Identifiers
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ONC-GYN-2402
Identifier Type: OTHER
Identifier Source: secondary_id
IRB00128756
Identifier Type: -
Identifier Source: org_study_id