Quantifying Systemic Immunosuppression to Personalize Cancer Therapy
Recruiting · NCT05621837 · Observational (researchers observe without assigning treatment) · Lead sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
View the official record on ClinicalTrials.gov →Interventions studied
MDSC quantification
What this trial is about
The Serpentine (Stratify cancER PatiENTs by ImmuNosupprEssion) project, represents the most consistent effort so far attempted to translate MDSC into clinical practise by producing an off-the-shelf compliant assay for quantifying these cells in peripheral blood.
Who can take part
Age range
18 Years to 90 Years
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- Histologically documented diagnosis of metastatic/locally advanced melanoma, hormone-refractory breast cancer, RCC and UC, SCCHN, SCC or NSCLC, stage III resectable NSCLC will also be included
- Will and ability to comply with the protocol
- Willingness and ability to provide an adequate archival Formalin-Fixed Paraffin-Embedded (FFPE) tumor sample available for exploratory biomarker analysis
- Age from 18 to 90 years at the time of recruitment
- ECOG Performance Status \<= 2
- Understanding and signature of the informed consent
- Consenting to participate to the socio-economical-psychological survey
Exclusion criteria
- Known history of HIV infection
- Serious neurological or psychiatric disorders
- Pregnancy or lactation
- Inability or unwillingness of participant to give written informed consent
- Inability or unwillingness to be regularly followed up at the same center
Where it is running
1 location listed.
- Fondazione IRCCS Istituto Nazionale dei Tumori - Milan, Italy