Evaluating mutations in solid tumors using liquid biopsy and genome sequencing

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to assess the prevalence of clinically relevant mutations in patients with advanced solid tumors through the use of liquid biopsy and next-generation sequencing (NGS) methods. By analyzing circulating tumor DNA (ctDNA), the study seeks to identify potential biomarkers that indicate treatment sensitivity or resistance. The findings could help optimize therapy selection for patients undergoing various lines of treatment for conditions such as colon-rectal cancer, gastric cancer, and breast cancer. The study will involve patients who are already receiving standard therapies and will focus on real-world data collection.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Patients eligible for inclusion in this study have to meet all of the following criteria:

* Patients, 18 years of age or older
* Competent and able to comprehend, sign and date an Ethics Committee (EC) approved Informed Consent Form (ICF) before performance of any study-specific procedures or tests
* Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
* Histologically proven diagnosis solid tumor
* Diagnosis of advanced or locally advanced disease
* Patients candidated to receive standard therapy in the following line:
* first, second or third-line therapy for colon-rectal cancer in IV stage
* first or second-line therapy for gastric cancer in IV stage
* primary intent or first-line therapy for pancreatic cancer
* first-line therapy for bile duct cancer
* first or second-line therapy for hepatocarcinoma
* first, second, third, fourth or fifth-line therapy for breast cancer in IV stage
* chemotherapy for ovarian cancer in advanced stage (FIGO III-IV) and at the time of first relapse
* first or second-line therapy for endometrial cancer in advanced stage (FIGO III-IV)
* first or second-line therapy for advanced or locally advanced cervical cancer
* therapy for locally advanced or first line therapy for metastatic vulva cancer
* first, second or third-line therapy for melanoma (third-line therapy only in BRAF-mutated melanoma)

Exclusion Criteria:

* Diagnosis of any secondary malignancy within the last 3 years, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix.
* Patients unable or unwilling to undergo as per protocol assessments at the four planned timepoints

Where it's running

• IRCCS, Centro di Riferimento Oncologico (CRO) di Aviano
  Aviano, Pordonone, Italy Recruiting

Study contacts

• Principal investigator: Fabio Puglisi, MD, PhD — IRCCS-Centro di Riferimento Oncologico (CRO), Aviano (PN)
• Study coordinator: Fabio Puglisi, MD, PhD
• Email: fabio.puglisi@cro.it
• Phone: 0434659253

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.