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Recruiting NCT04510766

Tumor Molecular Profiling in Early Phase Clinical Trials

— Observational Advanced Solid Tumor Lymphoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Advanced Solid Tumor, Lymphoma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Switzerland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Molecular Characterization of Solid Tumors and Lymphomas to Optimize the Drug Development Process and Patients Enrollment in Early Phase Clinical Trials

Overview

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.

Primary outcome measures

  • Accrual rate in early phase clinical trials [Time frame: Two years]
Secondary outcome measures (4)
  • Clinical Outcome [Time frame: Two years]
  • Number of successful NGS-based DNA analysis performed on archival tissue [Time frame: Two years]
  • Number of NGS-based RNA-seq samples analyzed [Time frame: Two years]
  • Rate of stored samples [Time frame: Two years]

Eligibility criteria

Inclusion criteria

  • 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.
  • Availability of FFPE archival tumor tissue from previous surgery or diagnostic biopsy adequate for molecular analysis.
  • Ability to understand the patient information and study consent. Signed and dated written informed consent must be available before performing any study-related procedure.
  • Willing and able to comply with study procedures

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

Switzerland · 1 center
  • Oncology Institute of Southern Switzerland — Bellinzona

Identifiers

NCT: NCT04510766 · IOSI-USNF-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗