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Circulating Tumor DNA Study in Patients With Endometrial Cancer

NCT05955079UNKNOWNOBSERVATIONAL

Summary

The objective of this study is to identify a population at risk of early recurrence after oncologic resection surgery of a primary uterine tumor based on the detection of ctDNA

Key Facts

Lead Sponsor

Assistance Publique - Hôpitaux de Paris

Enrollment

130

Start Date

2021-01-01

Completion Date

2024-10-01

Study Type

OBSERVATIONAL

Official Title

Prospective Validation of the Association Between Circulating Tumor DNA Detection and Risk of Metastatic Relapse in Patients With Localized Endometrial Cancer

Interventions

Whole blood

Conditions

Endometrial Cancer

Eligibility

Age Range

18 Years+

Sex

FEMALE

Inclusion Criteria:

* Female patients over 18 years of age who are potentially eligible for inclusion in the OncoCentre collection (registered as a patient at APHP, without legal protection measures, affiliated with a social security system)
* Patients diagnosed with histologically documented endometrial cancer on an endometrial biopsy
* Surgical intervention performed at Hopital Cochin

Exclusion Criteria:

* Failure to sign the OncoCentre consent form
* Refusal of OncoCentre consent
* Patient not eligible for upfront curative surgical treatment

Outcome Measures

Primary Outcomes

Recurrence-free survival

Time frame: 1 year

Secondary Outcomes

Recurrence-free survival

Time frame: 3 years

Frequency of ctDNA detection based on established prognostic parameters

Frequency of ctDNA detection based on established prognostic parameters: histological type (endometrioid, non-endometrioid), grade (low grade, high grade), stage (localized to the uterus stages I-II or stage III with nodal involvement), lymphovascular invasion (present/absent), and molecular group (low risk: POLE, intermediate risk: MSI/NSMP, high risk: TP53).

Time frame: 3 years

Frequency of ctDNA detection in other prognostic groups

Frequency of ctDNA detection in other prognostic groups according to the 2021 ESGO-ESTRO-ESP classification

Time frame: 3 years

Frequency of ctDNA detection based on the recurrence profile

Frequency of ctDNA detection based on the recurrence profile : anatomical (locoregional versus distant; abdominal versus extra-abdominal; visceral or nodal) or dynamic (aggressive recurrence (progression-free survival post recurrence \<6 months) or non-aggressive (\>6 months))

Time frame: 3 years

Locations

Hôpital Cochin, Paris, France

Linked Papers

2020-08-04

Molecular Classification of the PORTEC-3 Trial for High-Risk Endometrial Cancer: Impact on Prognosis and Benefit From Adjuvant Therapy

PURPOSE The randomized Adjuvant Chemoradiotherapy Versus Radiotherapy Alone in Women With High-Risk Endometrial Cancer (PORTEC-3) trial investigated the benefit of combined adjuvant chemotherapy and radiotherapy (CTRT) versus radiotherapy alone (RT) for women with high-risk endometrial cancer (EC). Because The Cancer Genome Atlas defined an EC molecular classification with strong prognostic value, we investigated prognosis and impact of chemotherapy for each molecular subgroup using tissue samples from PORTEC-3 trial participants. METHODS Paraffin-embedded tissues of 423 consenting patients were collected. Immunohistochemistry for p53 and mismatch repair (MMR) proteins, and DNA sequencing for POLE exonuclease domain were done to classify tumors as p53 abnormal (p53abn), POLE-ultramutated ( POLEmut), MMR-deficient (MMRd), or no specific molecular profile (NSMP). The primary end point was recurrence-free survival (RFS). Kaplan-Meier method, log-rank test, and Cox model were used for analysis. RESULTS Molecular analysis was successful in 410 high-risk EC (97%), identifying the 4 subgroups: p53abn EC (n = 93; 23%), POLEmut (n = 51; 12%), MMRd (n = 137; 33%), and NSMP (n = 129; 32%). Five-year RFS was 48% for patients with p53abn EC, 98% for POLEmut EC, 72% for MMRd EC, and 74% for NSMP EC ( P < .001). The 5-year RFS with CTRT versus RT for p53abn EC was 59% versus 36% ( P = .019); 100% versus 97% for patients with POLEmut EC ( P = .637); 68% versus 76% ( P = .428) for MMRd EC; and 80% versus 68% ( P = .243) for NSMP EC. CONCLUSION Molecular classification has strong prognostic value in high-risk EC, with significantly improved RFS with adjuvant CTRT for p53abn tumors, regardless of histologic type. Patients with POLEmut EC had an excellent RFS in both trial arms. EC molecular classification should be incorporated in the risk stratification of these patients as well as in future trials to target specific subgroups of patients.

2020-07-21

Tumor-related mutations in cell-free DNA in pre-operative plasma as a prognostic indicator of recurrence in endometrial cancer

Circulating tumor DNA (ctDNA) has potential as a basis for understanding the molecular features of a tumor non-invasively and for use as a diagnostic, prognostic, and disease-monitoring marker. The aim of this study was to evaluate the clinical roles of ctDNA in patients with endometrial cancer. Since Somatic Tumor-related ctDNA detected in plasma before surgery was associated with poorer oncologic outcome on univariate analysis in patients with endometrial cancer harboring

Highly Specific Droplet-Digital PCR Detection of Universally Methylated Circulating Tumor DNA in Endometrial Carcinoma

Abstract Background No circulating biomarker is available for endometrial carcinoma (EC). We aimed to identify DNA positions universally hypermethylated in EC, and to develop a digital droplet PCR (ddPCR) assay for detection of hypermethylated circulating tumor DNA (meth-ctDNA) in plasma from patients with EC. Methods DNA positions hypermethylated in EC, and without unspecific hypermethylation in tissue/cell types releasing circulating cell-free DNA in plasma, were identified in silico from TCGA/Gene Expression Omnibus (GEO) data. A methylation-specific ddPCR (meth-ddPCR) assay following bisulfite conversion of DNA extracted from plasma was optimized for detection of meth-ctDNA according to dMIQE guidelines. Performances were validated on a retrospective cohort (n = 78 tumors, n = 30 tumor-adjacent tissues), a prospective pilot cohort (n = 33 stage I–IV patients), and 55 patients/donors without cancer. Results Hypermethylation of zinc finger and SCAN domain containing 12 (ZSCAN12) and/or oxytocin (OXT) classified EC samples from multiple noncancer samples with high diagnostic specificity/sensitivity [&gt;97%; area under the curve (AUC) = 0.99; TCGA/GEO tissues/blood samples]. These results were confirmed in the independent retrospective cohort (AUC = 0.99). Meth-ddPCR showed a high analytical specificity (limit of blank = 2) and sensitivity (absolute lower threshold of detection = 50 pgmethDNA/mLplasma). In the pilot cohort, meth-ctDNA was detected in pretreatment plasma samples from 9/11 and 5/20 patients with advanced and non-advanced EC, respectively. 2 of 9 patients had ctDNA detected after macroscopic complete surgery and experienced progression within 6 months. No healthy donors had any copy of hypermethylated DNA detected in plasma. Conclusions Meth-ddPCR of ZSCAN12/OXT allows a highly specific and sensitive detection of ctDNA in plasma from patients with EC and appears promising for personalized approaches for these patients.

Endometrial Cancer