Clinical trial NCT04510766: Tumor Molecular Profiling in Early Phase Clinical Trials
Official title: Molecular Characterization of Solid Tumors and Lymphomas to Optimize the Drug Development Process and Patients Enrollment in Early Phase Clinical Trials
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Advanced Solid Tumor
Lymphoma
Lead sponsor: Oncology Institute of Southern Switzerland
Sponsor class: OTHER
Collaborators: name: Ente Ospedaliero Cantonale, Bellinzona
name: Istituto Cantonale di Patologia
First posted: 2020-08-12
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with histological diagnosis of advanced solid tumor or lymphoma who are potential candidates for early phase clinical trials

Brief summary: Prospective, single centre, non-interventional exploratory research project that will be conducted on biological material and health-related personal data collected.

Detailed description: Single center, two-parts pilot, prospective study to assess the role of molecular tumor profiling in supporting patient enrollment in early phase clinical trials.

Part A: patients with solid tumors or lymphomas (n=40) who are potential candidates for early phase clinical trials will be offered to have their more recent archival tumor tissue analyzed for the presence of somatic genomic alterations with the pan-cancer NGS Ion TorrentTM OncomineTM Comprehensive Assay v3 platform.

Part B: patients who have been enrolled in early phase clinical trials (estimated number: 16-18) will have their archival tumor tissue assessed with HTG EdgeSeq Oncology Biomarker Panel Assay for RNA-Seq to explore gene expression signatures and blood collected and stored to create a repository of samples (¨liquid biopsy¨) for future research with the aim to investigate the mutational profile of ctDNA at baseline and the acquisition of new mutations at the time of disease progression as a consequence of treatment exposure.

Eligibility criteria: Inclusion Criteria:

1. Male or female patients age at least 18 years.
2. Patients with histological diagnosis of advanced solid tumor or lymphoma who are potential candidates for early phase clinical trials.
3. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
4. Live expectancy of at least 6 months.
5. Availability of FFPE archival tumor tissue from previous surgery or diagnostic biopsy adequate for molecular analysis.
6. Ability to understand the patient information and study consent. Signed and dated written informed consent must be available before performing any study-related procedure.
7. Willing and able to comply with study procedures

Exclusion Criteria:

1. 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.
2. 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.

Primary outcomes:
measure: Accrual rate in early phase clinical trials
timeFrame: Two years
Secondary outcomes:
measure: Clinical Outcome
timeFrame: Two years
measure: Number of successful NGS-based DNA analysis performed on archival tissue
timeFrame: Two years
measure: Number of NGS-based RNA-seq samples analyzed
timeFrame: Two years
measure: Rate of stored samples
timeFrame: Two years
Other outcomes:
Locations:
city: Bellinzona
country: Switzerland
facility: Oncology Institute of Southern Switzerland
Study officials:
affiliation: Oncology Institute of Southern Switzerlan
name: Ilaria Colombo, MD
role: PRINCIPAL_INVESTIGATOR
References: