An observational study in Ovarian Neoplasms, sponsored by Chongqing University Cancer Hospital. Status unknown at 1 site in China. Open to female participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-08-31.
Sponsored by Chongqing University Cancer Hospital · Observational
Most ovarian cancer will relapse after standard therapy. Patients with recurrent ovarian cancer are resistant to platinum. Due to the high heterogeneity between ovarian cancer, individual precise therapy is of great importance. The study will establish ovarian cancer organoids, whose original tissues from the patients with advanced or recurrent ovarian cancer, their tumors cannot be excised completely. The organoids will be identified at the histopathological level and gene level for evaluating the consistency with the original tumor tissue. The drug's sensitivity and specificity are detected through the organoids model. Compared with the clinical efficiency of the actual drug regimen, the efficacy of the organoid drug screening model can be assessed. The aim is to construct a precise drug screening platform for advanced and recurrent ovarian cancer patients and innovate drug research and development.
This trial is a single-arm and prospective observational study. The subjects are the advanced or recurrent ovarian cancer patients, who are planned to undergo surgery, but the neoplastic lesions can't be excised thoroughly. They voluntarily participate in the study and sign an informed consent form. General information will be collected, including name, age, address and contact information. Comprehensive physical examination will be performed. Ovarian cancer tumor markers and imaging examinations (gastroenterostomy, ultrasound / CT / MRI or PET / CT) should be taken within 4 weeks before treatment. Histopathological and genetic characteristics were analyzed in organoids and paired primary tumors to confirm whether organoids faithfully recapitulated the original tumor tissues. The sensitivity and specificity of first-line and second-line drugs from NCCN guidelines will be detected on the organoids. Ovarian cancer (CA125、HE4、CEA、CA-199) markers will be tested within one week. After the treatment period of 3 and 6 months, the short-term efficacy will be evaluated according to the efficacy evaluation standard of solid tumor (Recist1.1) (the window period is 4 weeks). Biochemical indexes, adverse reactions, and prognosis (PFS, OS) will be followed. Compared with the efficacy of the actual clinical regimen, the potency of organoid as a drug screening model will be assessed.
2,759 studies on the registry are indexed under Ovarian Neoplasms; 735 are open to participants now.
This study's planned enrollment of 30 is below the median of 200 across 537 observational studies indexed under Ovarian Neoplasms.
Browse Ovarian Neoplasms studies →Chongqing University Cancer Hospital is the lead sponsor of 43 studies on the registry; 29 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The patients with advanced or recurrent ovarian cancer, who are planned to undergo surgery, but the tumour cannot be excised thoroughly. They voluntarily participate in the study and sign an informed consent form.
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:
Progression-free Survival
Progression-free survival means the duration from enrollment to disease progression or death.
Time frame: 2 years
Overall survival
Overall survival means the duration from enrollment to death due to any cause. The last follow-up time is calculated as the death time for subjects who lost follow-up.
Time frame: 2 years
Plan to share: No — These individual participant data (IPD) involves patients' informed consent and our technical confidentiality.
Started Mar 2022 (actual). Primary completion is estimated for Dec 2024, 33 months after the start.
Of 197 non-industry observational studies under Ovarian Neoplasms, half reached primary completion within 70 months of starting (the median), counting those still running; a quarter within 38 and three quarters within 238. This study's planned 33 months is below that.
Counting every sponsor, half of 238 studies reached it within 59 months; a quarter within 35 and three quarters within 152.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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Chongqing University Cancer Hospital