Epithelial Ovarian CancerNCT07764133
Whole Body Metabolic Activity as a Reflection of Tumor Metabolic Dysregulation and a Predictor of Treatment Response in Ovarian Cancer
An observational study of Epithelial Ovarian Cancer, run by University of Tennessee Graduate School of Medicine at 1 site in United States.
Trial summary
The primary objectives of the study are: 1. To delineate commonly utilized tumor metabolic alterations in ovarian cancer. These metabolic alterations will be explored for potentially targetable pathways to restore chemotherapy responsiveness. 2. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Epithelial Ovarian Cancer
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 13 May 2026to 13 May 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with ovarian cancer receiving care at the study institution will be recruited for participation. Potential participants will be identified through their treating physicians and/or clinical care teams during routine clinical encounters, as well as through review of medical records for eligibility. The study population will include adults with ovarian cancer who are undergoing standard-of-care treatment, including surgery and/or chemotherapy, and who meet the study inclusion criteria. Participants will be followed prospectively to assess whole-body metabolic activity, tumor metabolic characteristics, and treatment-related outcomes. Efforts will be made to enroll a diverse group of participants representative of the patient population served by the institution.
Who may be able to join
- Women
- Age >18 years
- Suspected of having epithelial ovarian cancer by the provider
- No prior cytotoxic therapy for ovarian cancer
- Surgical debulking is planned
- ECOG performance status 0-1
Who cannot join
- Inability to provide voluntary informed consent
- Received medical intervention for adverse effects of chemotherapy
- Circumstances and/or medical conditions that would limit compliance with study requirements and protocol, as determined by the principal investigators.
- Poorly controlled diabetes, hemoglobin A1C ≥9%
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Tennessee Medical Center - Knoxville
Knoxville, Tennessee, 37920
Lina Reyes Fontalvo Research Coordinator, 865-305-9987, LFontalvo@utmck.edu
About this study
The primary objectives of the study are:
- To delineate commonly utilized tumor metabolic alterations in ovarian cancer. These metabolic alterations will be explored for potentially targetable pathways to restore chemotherapy responsiveness.
- To define the relationship between whole-body metabolic activity as measured via indirect calorimetry with ex vivo measure of tumor metabolic activity. The secondary objectives of the study are:
- To evaluate longitudinal changes in whole-body metabolic activity over the course of cytotoxic chemotherapy and evaluate these changes as they relate to oncologic outcomes and treatment-free interval.
- To examine the impact of tumor metabolic alterations on healthy non-malignant tissues and serum metabolites.
- An additional exploratory objective is to collect data that will contribute to a more holistic understanding of the whole-body metabolic effects of ovarian cancer. Based on prior studies, surveys have been an effective method for capturing the social, psychological, and behavioral factors associated with the disease. It is possible that changes in metabolism and inflammation are mediated by these psychosocial factors that ultimately impact response to cancer therapy.
It is hypothesized that whole-body metabolic activity as measured via indirect calorimetry can be utilized as a non-invasive surrogate to reflect tumor metabolic dysregulation in patients with ovarian cancer. Moreover, it is hypothesized that there will be an inverse relationship between treatment-free interval and the metabolic rate when measured at a whole-body level and an increased rate of glycolysis when measured within the tumor microenvironment. To address these hypotheses, the study will pursue the specific aims listed above.
Read the detailed description
The dates of all study visits (seven in total) will be coordinated with each participant according to the anticipated chemotherapy schedule. If a participant enrolled in the study is found to have a non-gynecologic malignancy or benign pathology at the time of surgery, no further postoperative study visits will be completed.
There are a total of seven planned study visits.
Five study visits will include whole-body metabolic assessments:
- Prior to initiation of therapy or before surgical debulking (SV1).
- Four to six weeks after surgical debulking and before initiation of adjuvant chemotherapy (this timing is part of the standard of care) (SV3).
- Prior to cycle 3 of chemotherapy (SV4). This study visit will occur in conjunction with a scheduled chemotherapy visit.
- Prior to cycle 6 of chemotherapy (SV5). This study visit will occur in conjunction with a scheduled chemotherapy visit.
- Six months after completion of chemotherapy (SV7).
Two additional study visits (SV2 and SV6) will include vital sign and anthropometric assessments and blood collection.
- Blood samples will be collected for future ancillary testing, including circulating tumor DNA and serum metabolite analyses. Banked blood samples will be analyzed only after completion of study participation to minimize potential implications for clinical care, as circulating tumor DNA analysis remains experimental in ovarian cancer.
- Prior to surgical debulking (SV2). This study visit will be required only for participants who receive neoadjuvant chemotherapy before surgery. For participants who do not receive neoadjuvant chemotherapy, these assessments will be completed during SV1.
- Three months after completion of chemotherapy (SV6).
Direct participant involvement in the study ends after completion of the final study visit. The participant's electronic medical record (EMR) will be reviewed every six months until disease recurrence to collect oncologic outcome data, including progression-free survival and treatment-free interval.
- Conditions
- Epithelial Ovarian Cancer
- Medical subject headings
- Carcinoma, Ovarian Epithelial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Ovarian Cancer Cohort | Patients with ovarian cancer undergoing standard-of-care treatment who will undergo serial whole-body metabolic assessments, biospecimen collection, and clinical follow-up to evaluate the relationship between systemic metabolic activity, tumor metabolic characteristics, and treatment outcomes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in resting metabolic rate
Measured: prior to treatment [SV1], after debulking surgery [SV3], prior to cycle #3 chemotherapy [SV4], prior to cycle #6 chemotherapy [SV5], and 6 months after completion of chemotherapy [SV7]
Change in respiratory quotient
Measured: prior to treatment [SV1], after debulking surgery [SV3], prior to cycle #3 chemotherapy [SV4], prior to cycle #6 chemotherapy [SV5], and 6 months after completion of chemotherapy [SV7]
Change in carbon dioxide production
Measured: prior to treatment [SV1], after debulking surgery [SV3], prior to cycle #3 chemotherapy [SV4], prior to cycle #6 chemotherapy [SV5], and 6 months after completion of chemotherapy [SV7]
Change in oxygen consumption
Measured: prior to treatment [SV1], after debulking surgery [SV3], prior to cycle #3 chemotherapy [SV4], prior to cycle #6 chemotherapy [SV5], and 6 months after completion of chemotherapy [SV7]
Change in metabolic flexibility
Measured: prior to the treatment [SV1] and six months after completion of chemotherapy [SV7]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2026
- Study start13 May 2026
- Primary completion13 May 2028 (estimated)
- Study completion13 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epithelial Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Tennessee Graduate School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07764133
- Sponsor's protocol ID
- 5542
- Status last verified
- Jul 2026
- First submitted
- 5 Aug 2026
- Last updated
- 17 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Whole Body Metabolic Activity as a Reflection of Tumor Metabolic Dysregulation and a Predictor of Treatment Response in Ovarian Cancer
- ClinicalTrials.gov ID
- NCT07764133
- Acronym / sponsor ID
- 5542
- Conditions
- Epithelial Ovarian Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of Tennessee Graduate School of MedicineUniversity, hospital or other
- Study start
- 13 May 2026 (actual)
- Primary completion
- 13 May 2028 (estimated)
- Study completion
- 13 May 2028 (estimated)
- First posted
- 13 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objectives of the study are:
- To delineate commonly utilized tumor metabolic alterations in ovarian cancer. These metabolic alterations will be explored for potentially targetable pathways to restore chemotherapy responsiveness.
- To define the relationship between whole-body metabolic activity as measured via indirect calorimetry with ex vivo measure of tumor metabolic activity. The secondary objectives of the study are:
- To evaluate longitudinal changes in whole-body metabolic activity over the course of cytotoxic chemotherapy and evaluate these changes as they relate to oncologic outcomes and treatment-free interval.
- To examine the impact of tumor metabolic alterations on healthy non-malignant tissues and serum metabolites.
- An additional exploratory objective is to collect data that will contribute to a more holistic understanding of the whole-body metabolic effects of ovarian cancer. Based on prior studies, surveys have been an effective method for capturing the social, psychological, and behavioral factors associated with the disease. It is possible that changes in metabolism and inflammation are mediated by these psychosocial factors that ultimately impact response to cancer therapy.
It is hypothesized that whole-body metabolic activity as measured via indirect calorimetry can be utilized as a non-invasive surrogate to reflect tumor metabolic dysregulation in patients with ovarian cancer. Moreover, it is hypothesized that there will be an inverse relationship between treatment-free interval and the metabolic rate when measured at a whole-body level and an increased rate of glycolysis when measured within the tumor microenvironment. To address these hypotheses, the study will pursue the specific aims listed above.
Detailed description
The dates of all study visits (seven in total) will be coordinated with each participant according to the anticipated chemotherapy schedule. If a participant enrolled in the study is found to have a non-gynecologic malignancy or benign pathology at the time of surgery, no further postoperative study visits will be completed.
There are a total of seven planned study visits.
Five study visits will include whole-body metabolic assessments:
- Prior to initiation of therapy or before surgical debulking (SV1).
- Four to six weeks after surgical debulking and before initiation of adjuvant chemotherapy (this timing is part of the standard of care) (SV3).
- Prior to cycle 3 of chemotherapy (SV4). This study visit will occur in conjunction with a scheduled chemotherapy visit.
- Prior to cycle 6 of chemotherapy (SV5). This study visit will occur in conjunction with a scheduled chemotherapy visit.
- Six months after completion of chemotherapy (SV7).
Two additional study visits (SV2 and SV6) will include vital sign and anthropometric assessments and blood collection.
- Blood samples will be collected for future ancillary testing, including circulating tumor DNA and serum metabolite analyses. Banked blood samples will be analyzed only after completion of study participation to minimize potential implications for clinical care, as circulating tumor DNA analysis remains experimental in ovarian cancer.
- Prior to surgical debulking (SV2). This study visit will be required only for participants who receive neoadjuvant chemotherapy before surgery. For participants who do not receive neoadjuvant chemotherapy, these assessments will be completed during SV1.
- Three months after completion of chemotherapy (SV6).
Direct participant involvement in the study ends after completion of the final study visit. The participant's electronic medical record (EMR) will be reviewed every six months until disease recurrence to collect oncologic outcome data, including progression-free survival and treatment-free interval.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ovarian Cancer Cohort | – | –Patients with ovarian cancer undergoing standard-of-care treatment who will undergo serial whole-body metabolic assessments, biospecimen collection, and clinical follow-up to evaluate the relationship between systemic metabolic activity, tumor metabolic characteristics, and treatment outcomes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with ovarian cancer receiving care at the study institution will be recruited for participation. Potential participants will be identified through their treating physicians and/or clinical care teams during routine clinical encounters, as well as through review of medical records for eligibility. The study population will include adults with ovarian cancer who are undergoing standard-of-care treatment, including surgery and/or chemotherapy, and who meet the study inclusion criteria. Participants will be followed prospectively to assess whole-body metabolic activity, tumor metabolic characteristics, and treatment-related outcomes. Efforts will be made to enroll a diverse group of participants representative of the patient population served by the institution.
Key inclusion criteria (6 listed)
- Women
- Age >18 years
- Suspected of having epithelial ovarian cancer by the provider
- No prior cytotoxic therapy for ovarian cancer
- Surgical debulking is planned
Key exclusion criteria (4 listed)
- Inability to provide voluntary informed consent
- Received medical intervention for adverse effects of chemotherapy
- Circumstances and/or medical conditions that would limit compliance with study requirements and protocol, as determined by the principal investigators.
- Poorly controlled diabetes, hemoglobin A1C ≥9%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in resting metabolic rate
Time frame: prior to treatment [SV1], after debulking surgery [SV3], prior to cycle #3 chemotherapy [SV4], prior to cycle #6 chemotherapy [SV5], and 6 months after completion of chemotherapy [SV7]
Change in respiratory quotient
Time frame: prior to treatment [SV1], after debulking surgery [SV3], prior to cycle #3 chemotherapy [SV4], prior to cycle #6 chemotherapy [SV5], and 6 months after completion of chemotherapy [SV7]
Change in carbon dioxide production
Time frame: prior to treatment [SV1], after debulking surgery [SV3], prior to cycle #3 chemotherapy [SV4], prior to cycle #6 chemotherapy [SV5], and 6 months after completion of chemotherapy [SV7]
Change in oxygen consumption
Time frame: prior to treatment [SV1], after debulking surgery [SV3], prior to cycle #3 chemotherapy [SV4], prior to cycle #6 chemotherapy [SV5], and 6 months after completion of chemotherapy [SV7]
Change in metabolic flexibility
Time frame: prior to the treatment [SV1] and six months after completion of chemotherapy [SV7]
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
University of Tennessee Medical Center - Knoxville
Knoxville, United States
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epithelial Ovarian Cancer, run by University of Tennessee Graduate School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in resting metabolic rate (time frame: prior to treatment [SV1], after debulking surgery [SV3], prior to cycle #3 chemotherapy [SV4], prior to cycle #6 chemotherapy [SV5], and 6 months after completion of chemotherapy [SV7]). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.