BMX-001 + Paclitaxel in Adult Patients With Advanced, Recurrent, Metastatic Ovarian or Endometrial Cancer
NCT06620029
Adnexal Diseases, Endocrine Gland Neoplasms
Durham, North Carolina, United States
View Trial DetailsNCT Number: NCT07006103
In recent years, knowledge about cancer biology has expanded significantly. The study of gene expression profiles has revealed the heterogeneous nature and potential reclassification of the various tumor subtypes based on specific genetic alterations. This is of great importance since it allows a therapeutic approach more directed to the intrinsic characteristics of each tumor (precision medicine).
Integrating clinicopathological information with molecular classification could provide new guidelines when approaching patients with EC, both in preoperative assessment and in adjuvant treatment and surveillance.
The application of molecular classification in endometrial carcinomas shows a subgroup of patients with an excellent prognosis, corresponding to the POLEmut subgroup that could be reclassified with eventual therapeutic de-escalation.
The clinical guidelines for the management of patients with endometrial cancer proposed by ESGO/ESTRO/ESP in 2020 recommend the use of this new classification, and warn that clinical management may be modified by the molecular classification in scenarios where adjuvant chemotherapy is considered (high-grade/high-risk disease).
Trial opening soon.
Get Notified18 year and older
Female
Observational
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: At study inclusion (retrospective evaluation of cases from the last 5 years). Units: Percentage of patients per subtype
Proportion of patients in each of the four molecular subtypes of endometrial cancer (POLE-ultramutated, microsatellite instability hypermutated, copy-number low, copy-number high) determined using immunohistochemistry for MMR proteins and TP53, and NGS-based sequencing of the POLE gene.
Time frame: At study inclusion (retrospective evaluation of cases from the last 5 years).
Proportion of patients with low- versus high-risk histological types within each molecular subtype.
Time frame: At study inclusion (retrospective evaluation of cases from the last 5 years).
Time (in months) from diagnosis to first documented relapse, stratified by molecular subtype.
Contact information is provided by the study sponsor or research team.
Hernan García Rivello MD, PhD
CONTACT
+54 11 4959 0200 ext. 9210
Romina Albite D Bsc, Phd
CONTACT
+54 11 4959 0200 ext. 5168
Hospital Italiano de Buenos Aires
Other
Precision Medicine Applied to Endometrial Cancer (EC)
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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