International Survival Follow-up of Patients Enrolled In the Renal Cell Carcinoma Evaluation of Adjuvant Oncophage® Treatment in the Antigenics C-100-12 (Part I) Protocol.(INSPIRE) - INSPIRE
- Conditions
- Renal Cell CarcinomaMedDRA version: 9.1Level: LLTClassification code 10038395Term: Renal carcinoma
- Registration Number
- EUCTR2007-007460-22-AT
- Lead Sponsor
- Antigenics Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 436
To be eligible, patients must have
1. Participated in the Antigenics C-100-12 (part I) protocol, and terminated the study with last survival status reported as 'alive' and due to 'administrative study closure'
2. Signed an informed consent to participate in the C-100-27 Survival Follow-up protocol, and be willing to receive contact from a representative from the protocol investigative study centers and/or any subsequently identified co-investigator sites where patients consent to continued survival follow-up and/or a member from a company designated by the Sponsor every 6 months if no disease recurrence and every 3 months if disease has recurred.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Not provided
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method