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Quantifying Systemic Immunosuppression to Personalize Cancer Therapy

ConditionsMelanomaBreast CancerRenal Cell CarcinomaUrinary Bladder CancerSquamous Cell Carcinoma of Head and NeckSmall Cell CarcinomaNSCLC
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-90
SponsorFondazione IRCCS Istituto Nazionale dei Tumori, Milano

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

Known history of HIV infection

Serious neurological or psychiatric disorders

Pregnancy or lactation

Inability or unwillingness of participant to give written informed consent

Trial population

Patients with five diverse tumor histotypes (n=600) will be collected in parallel clinical case-sets, with power calculation estimated on the basis of MIS validation in melanoma (n=100 patients per histotypes, with the exception of the 200 patients to be enrolled for NSCLC). In addition, a group of age and gender-matched healthy donors (n=400) will be also included to provide normal values of the myeloid-related parameters under physiological conditions.

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • MDSC quantification

    Other intervention

    Blood sample will be collected at baseline and during therapy, and, optionally, in case of disease progression (PD).

Treatment groups

1,000 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: Metastatic melanoma patients1 intervention
Group B: hormone receptor positive/Human Epidermal growth factor Receptor-2 negative cancer patients1 intervention
Group C: Advanced RCC(renal cell carcinoma) patients1 intervention
Group D: SCCHN or SCC(Small Cell Carcinoma) patients1 intervention
Group E: NSCLC patients1 intervention
Group F: Age and gender-matched healthy donors1 intervention

Trial outcomes

Primary outcomes

1

Immunological endpoint

Frequency, in terms of percentage and absolute count of the defined cell subsets in whole blood and stored PBMC

Time frame
baseline, that is prior to start the therapy (Visit_1)
2

Immunological endpoint

Frequency, in terms of percentage and absolute count of the defined cell subsets in whole blood and stored PBMC

Time frame
around one month/before the time-corresponding treatment cycle (Visit_2)
3

Immunological endpoint

Frequency, in terms of percentage and absolute count of the defined cell subsets in whole blood and stored PBMC

Time frame
around three months/before the time-corresponding treatment cycle (Visit_3)
4

Immunological endpoint

Frequency, in terms of percentage and absolute count of the defined cell subsets in whole blood and stored PBMC

Time frame
Through study completion, an average of 2 year

Secondary outcomes

1

Myeloid Index Score (MIS)

Myeloid Index Score (MIS)=0 vs MIS\>0 or higher values

Time frame
Through study completion, an average of 2 year
2

Index score values

Index score values on plasma cytokine concentration or MDSC-miRs

Time frame
Through study completion, an average of 2 year
3

Transcriptional signatures_PBMC

Transcriptional signatures identified on PBMC and sorted myeloid cells form whole blood

Time frame
baseline, that is prior to start the therapy (Visit_1) or at the first disease evaluation (around after three months)
4

Transcriptional signatures_myeloid cells

Transcriptional signatures identified on sorted myeloid cells form whole blood

Time frame
baseline, that is prior to start the therapy (Visit_1) or at the first disease evaluation (around after three months)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Lead sponsor

Source ClinicalTrials.gov
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