An observational study in Epithelial Ovarian Cancer, sponsored by University of Tennessee Graduate School of Medicine. Recruiting at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-17.
Sponsored by University of Tennessee Graduate School of Medicine · Observational
The primary objectives of the study are:
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:
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.
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:
Two additional study visits (SV2 and SV6) will include vital sign and anthropometric assessments and blood collection.
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.
797 studies on the registry are indexed under Carcinoma, Ovarian Epithelial; 101 are open to participants now.
This study's planned enrollment of 50 is below the median of 200 across 91 observational studies indexed under Carcinoma, Ovarian Epithelial.
Browse Carcinoma, Ovarian Epithelial studies →University of Tennessee Graduate School of Medicine is the lead sponsor of 27 studies on the registry; 13 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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]
PDFs hosted by the registry, ClinicalTrials.gov.
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Carcinoma, Ovarian Epithelial →
University of Tennessee Graduate School of Medicine