NY-ESO solid tumors
Conditions
Interventions
Determination of the NY-ESO expression status in tumor tissue using the
investigational NY-ESO (SP511) CTA will be done as part of the screening
assessments. For specific cohorts, only patients with
Sponsors
Daiichi Sankyo, Inc.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: The study population of CPS-01-DS2243-054 includes samples of all subjects tested for NY-ESO expression status as part of the screening procedures of drug trial DS2243-054. Inclusion criteria for the drug trial are defined in section 5 of the drug trial protocol. Sample inclusion criteria are as follows: A pre-treatment tumor tissue sample collected within 6 months of Main consent and after completion of the most recent anticancer treatment regimen is preferred if available. If this is not available, archival tumor tissue samples collected more than 6 months prior to Main consent may be acceptable. A newly obtained tumor tissue sample is required if there is no pre-treatment or archival tumor tissue sample available. Formalin-fixed, paraffin-embedded tumor tissue specimens are required for this trial. Examples of acceptable specimens include resection or excisional biopsies, core needle biopsies and transbronchial forceps biopsies. Details related to sample requirements are provided in the Laboratory Manual: Briefly, tumor tissue will be collected using institutional standard practices and assigned a unique identifier. In the case of wet tissue collection, standard labeling and fixation processes will be performed as specified in the lab manual. Site staff will fill out the information in paper-based sample requisition form, and additional information will be entered on the RTD-Client Request Portal. For any additional information regarding shipping, handling, and holiday schedules, please refer to the lab manual.
Exclusion criteria
Exclusion criteria: The study population of CPS-01-DS2243-054 includes samples of all subjects tested for NY-ESO expression status as part of the screening procedures of drug trial DS2243-054. Exclusion criteria for the drug trial are defined in section 5 of the drug trial protocol. Sample exclusion criteria are as follows: Cryobiopsies, decalcified bone biopsies, and any cytological specimens including fine needle aspirates are not acceptable for this trial. Samples not fulfilling requirements defined in the lab manual.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The corresponding endpoint for this performance study CPS-01-DS2243-054 is NY-ESO expression levels detected in pre-treatment tumor tissue samples collected from participants of drug trial DS2243-054. | — |
Secondary
| Measure | Time frame |
|---|---|
| Additional endpoints may include: 1) Percentage of evaluable and non-evaluable cases 2) Percentage of samples requiring repeat staining due to rejection of the negative control (The negative marker control will be evaluated for acceptable signal/noise ratio and background staining) | — |
Countries
Netherlands
Outcome results
None listed