An observational study in Ovarian Cancer, Neoadjuvant Chemotherapy and Prognostic Cancer Model, sponsored by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University. Status unknown at 1 site in China. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-11-07.
Sponsored by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Observational
A validated prognostic index for the outcome of advanced high-grade serous ovarian cancer (HGSOC) patients undergoing neoadjuvant chemotherapy (NACT) is still lacking. To address this need, we developed an ovarian neoadjuvant chemotherapy prognostic index (ONCPI) to improve predictive accuracy. We analyzed the clinicopathological characteristics of advanced HGSOC patients receiving platinum-based NACT. Blood inflammatory composite markers were calculated and binary-transformed using optimal cutoffs. Omental hematoxylin and eosin (H\&E) stained slides were selected for the assessment of chemotherapy response score (CRS). Logistic regression analysis and Cox proportional hazards regression model were utilized to develop a prognostic index.
2,757 studies on the registry are indexed under Ovarian Neoplasms; 735 are open to participants now.
This study's planned enrollment of 465 is above the median of 200 across 537 observational studies indexed under Ovarian Neoplasms.
Browse Ovarian Neoplasms studies →Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University is the lead sponsor of 477 studies on the registry; 278 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with advanced HGSOC receiving platinum-based neoadjuvant chemotherapy (NACT) before interval debulking surgery (IDS) and postoperative adjuvant chemotherapy were enrolled
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:
Diagnostic Test: CRS scoring · Diagnostic Test: Routine blood laboratory testing before treatment
For pathological evaluation, the omental specimens resected during the IDS were stained with haematoxylin and eosin (H\&E) and reviewed independently by two gynecologic pathologists, both blinded to the clinical data and each other's results. The pathology slide obtained from omentum, usually the site with the most viable tumor, was selected for CRS assessment according to the three-tiered CRS system recommended by 2019 ESMO ovarian cancer guidelines
The routine blood tests and tumor marker measurements, including CA125, HE4, and inflammation-related serum biomarkers including neutrophils, lymphocytes, monocytes, fibrinogen, and platelets, were conducted within three days before the first NACT.
Response to platinum-based chemotherapy
After NACT-IDS and postoperative adjuvant chemotherapy, treatment efficacy was assessed according to NCCN guidelines. For primary tumor, patients who relapsed 6 months or more after initial chemotherapy were termed platinum-sensitive. In contrast, patients whose disease recurred in less than 6 months were classified as platinum-resistant.
Time frame: At least 6 months after initial chemotherapy
3-year progression-free survival (PFS)
PFS was calculated from the date of the first NACT until disease progression or death due to any cause.
Time frame: 3 years
3-year overall survival (OS)
OS was calculated from the date of the first NACT administration until death due to any cause.
Time frame: 3 years
Plan to share: Undecided — If IPD is to be shared, it will be limited to the patient's clinicopathological and prognostic data, and the patient's personal information will be protected
This study is status unknown, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University →