A multicentre observational study for the long term follow up of subjects that have been treated with enadenotucirev during interventional clinical trial
Phase 1
- Conditions
- Cancerincluding Breast, Ovarian, Colorectal, Metastatic colorectal(those investigated as part of previous trials using Enadenotucirev).Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2016-004777-40-BE
- Lead Sponsor
- PsiOxus Therapeutics Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 11
Inclusion Criteria
l. Have participated in a clinical trial during which they received
enadenotucirev, irrespective of the route of administration, dose received or tumour type being treated
2. Able and willing to provide signed and dated written informed consent
3. Able to comply with study procedures in the Investigator's opinion
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 5
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5
Exclusion Criteria
None
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To follow up subjects that have received enadenotucirev during a clinical trial to assess their long term well-being;Secondary Objective: To collect all cancer treatments received after discontinuing treatment with enadenotucirev.;Primary end point(s): Time to death;Timepoint(s) of evaluation of this end point: Visits or telephone contacts will take place at intervals no greater than every 3 months to assess subject well-being and record cancer treatments received.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Not applicable.;Timepoint(s) of evaluation of this end point: Not applicable