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

Overview

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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)

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