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Predictors of Node Positivity in Endometrial Cancer

NCT05793333RecruitingOBSERVATIONAL

Summary

To investigate the role of histological and moleculr profile of endometrial cancer patietns in predicting the risk of nodal metastases in endometrila cancer patients.

Key Facts

Lead Sponsor

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Enrollment

200

Start Date

2022-01-10

Completion Date

2024-12-31

Study Type

OBSERVATIONAL

Official Title

Histological and Molecular Characteristics Predict the Risk of Nodal Involvement in Endometrial Cancer: a Prospective Study

Conditions

Endometrial Cancer

Eligibility

Age Range

18 Years+

Sex

FEMALE

Inclusion Criteria:

* Written informed consent
* Histologically confirmed endometrila cancer
* Data on molecular genomic profiling (POLE mutated, p53 abnormalities, MMRd/MSI-H, and NSMP)
* Data on histological characteristics of the ttumor
* Execution of sentinel node mapping
* Data on sentinel node status (negative vs. positive)

Exclusion Criteria:

* Stage IVB endoemtrial cancer
* consent withdraw

Outcome Measures

Primary Outcomes

positive nodes

positive nodes detected by sentinel node mappinig

Time frame: 12 months

Locations

Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy

Linked Papers

2024-09-02

Predicting the Risk of nOdal disease with histological and Molecular features in Endometrial cancer: the prospective PROME trial

To assess the role of histopathological and molecular features in predicting the risk of nodal metastases in apparent early-stage endometrial cancer patients undergoing sentinel node mapping. This is a prospective trial. Consecutive patients with apparent early-stage endometrial cancer, undergoing laparoscopic hysterectomy, bilateral salpingo-oophorectomy, and sentinel node mapping, were enrolled. Histological and molecular features were used to predict the node positivity. Charts of 223 apparent early-stage endometrial cancer patients were included in this study. Four (1.8%) patients were excluded from this study due to the lack of data about molecular features. Additionally, nine (4%) patients did not meet the inclusion criteria (due to the presence of peritoneal carcinomatosis or bulky nodes (the presence of p53 abnormality correlated with the presence of advanced stage disease (p<0.001)). The study population included 178 (84.8%) and 32 (15.2%) patients with endometrioid and non-endometrioid endometrial cancer, respectively. According to pathological uterine risk factors, 93 (44.3%), 45 (21.4%), 40 (19.1%), and 32 (15.2%) were classified as low, intermediate, intermediate-high, and high-risk, respectively. Using the surrogate molecular classification, 10 (4.8%), 42 (20%), 57 (27.1%), and 101 (48.1%) were included in the POLE mutated, p53 abnormal, MMRd/MSI-H, and NSMP, respectively. Overall, 41 (19.5%) patients were detected with positive nodes. Molecular features were not associated with the risk of having nodal metastases (OR 1.03, 95% CI 0.21 to 5.05, p=0.969 for Our data suggest that molecular classification does not seem useful to tailor the need of nodal dissection in apparent early-stage endometrial cancer. p53 abnormality predicts the risk of having advanced disease at presentation. Further external validation is needed. NCT05793333.

Linked Investigators

Giorgio Bogani

Giovanni Scambia