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Genomic Assessment in Patients with Untreated Advanced Biliary Cancers and Germ Cell Tumors

Overview

Información sobre este estudio

The long term research goal and objective of this application is to improve the clinical outcomes of patients with biliary tract cancers and germ cell tumors. There is an imminent need to identify novel targets suitable for drug development in patients with these cancers given the need for novel therapeutics for patients diagnosed with BTCs and GCTs.

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

Registration – Inclusion Criteria

  • Either a) Suspected BTC undergoing standard of care image guided biopsy for diagnosis confirmation or b) suspected GCT undergoing standard of care orchiectomy or retroperitoneal lymph node dissection (RPLND)
  • Imaging (CT or MRI) completed ≤ 45 days prior to registration to document baseline characteristics of lesion undergoing biopsy (e.g., location, features, size, extent of local spread and lymph node status)
  • Age > 18 years
  • Willingness to provide tissue and blood samples for genomic analyses
  • International Normalized Ratio (INR) < 1.5 x ULN (within 14 days prior to registration)
  • PTT < 1.5 x ULN (within 14 days prior to registration)
  • Eastern Cooperative Group (ECOG) performance status (PS) of 0-2 (Appendix I)
  • Platelet count >70,000 /μL (within 14 days prior to registration)
  • Ability to provide informed consent

Registration – Exclusion Criteria

  • In the opinion of the investigator, unfit or unsuitable to undergo standard of care image guided biopsy procedure or orchiectomy
  • Malignancy other than biliary tract cancer (BTC) or Germ cell tumors (GCTs)

 

More information

Publicaciones

Publications are currently not available

Otros temas en investigación

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CLS-20309303

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