Tumor Molecular Profiling in Early Phase Clinical Trials
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorOncology Institute of Southern Switzerland
About this trial
Prospective, single centre, non-interventional exploratory research project that will be conducted on biological material and health-related personal data collected.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male or female patients age at least 18 years.
Patients with histological diagnosis of advanced solid tumor or lymphoma who are potential candidates for early phase clinical trials.
Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
Live expectancy of at least 6 months.
Disqualifiers
Presence of any clinical (e.g. concomitant disease, clinically significant symptoms, or non-clinical (psychological or social) conditions that would not make the patient eligible for enrolment in an early phase clinical trial.
Any other active malignancy (other than the one for which the subject is being assessed for trial option) that is progressing or requiring active treatment with the exception of basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of any site.
Trial population
Patients with histological diagnosis of advanced solid tumor or lymphoma who are potential candidates for early phase clinical trials
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
40 Participants
are grouped into 2 trial groupsGroup A: Part A
Group B: Part B
Trial outcomes
Primary outcomes
1
Accrual rate in early phase clinical trials
Number of patients with available molecular profile enrolled per year
Time frame
Two yearsSecondary outcomes
1
Clinical Outcome
Response rate among patients with available molecular tumor profiling that have been enrolled in an early phase clinical trial
Time frame
Two years2
Number of successful NGS-based DNA analysis performed on archival tissue
Type and frequency of mutations identified on archival tissue
Time frame
Two years3
Number of NGS-based RNA-seq samples analyzed
Analysis performed on archival tissue
Time frame
Two years4
Rate of stored samples
Number of blood samples collected and stored for ctDNA analysis
Time frame
Two yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Oncology Institute of Southern Switzerland
Lead sponsor
Ente Ospedaliero Cantonale, Bellinzona
Collaborator
Istituto Cantonale di Patologia
Collaborator
Source ClinicalTrials.gov