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NCT Number: NCT06028724

A Study on the Prevalence of Clinically Useful Mutations in Solid Tumor Characterized by Next Generation Sequencing Methods on Liquid Biopsy Analysis (POPCORN)

The implementation of liquid biopsy in clinical practice has been favored by the rapid development of genome sequencing techniques designed to analyze mutations in ctDNA. Among these, the Next generation sequencing (NGS) is a technique that consists in sequencing several genomes in a short time span, collecting information about a wider range of genomic alterations, using small quantities of genetic material. It is used to identify potential circulating dynamic biomarkers of treatment sensitivity or resistance in a real word multi-pathology evaluation. In this way, defining the mutational status of clinical relevance genes in real world, as a predictive biomarker to identify those patients most likely to benefit from target therapy, offers the potential to optimize access to further therapies. The aim of this study is to evaluate the real-world prevalence of clinically useful mutations in patients who are receiving therapy for advanced and locally advanced solid tumor through liquid biopsy.

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Key information

Conditions

Solid Tumor Adenocarcinoma Adnexal Diseases Advanced Solid Tumor Bile Duct Cancer Bile Duct Diseases Bile Duct Neoplasms Biliary Tract Diseases Biliary Tract Neoplasms Breast Cancer Breast Diseases Breast Neoplasms Carcinoma Carcinoma, Hepatocellular Cervical Cancer Colon Rectal Cancer Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Endometrial Cancer Endometrial Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastric Cancer Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Hepatocarcinoma Intestinal Diseases Intestinal Neoplasms Liver Diseases Liver Neoplasms Locally Advanced Solid Tumor Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Ovarian Cancer Ovarian Diseases Ovarian Neoplasms Pancreatic Cancer Pancreatic Diseases Pancreatic Neoplasms Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases Stomach Diseases Stomach Neoplasms Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms Vulva Cancer Vulvar Diseases Vulvar Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS, Centro di Riferimento Oncologico (CRO) di Aviano

Aviano, Pordonone, 33081, Italy

Location status: Recruiting

Location contact

Fabio Puglisi, MD, PhD

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Real world prevalence of clinically useful mutations in solid tumors

    Time frame: at the beginning of treatment

    Real world prevalence of clinically useful mutations in solid tumors, defined as the proportion of patients with the detection of clinically useful mutations through ctDNA NGS, at the beginning of systemic therapies defined as per inclusion criteria for advanced disease.

Secondary outcomes

  1. To identify emerging gene alterations associated with Progression Free Survival

    Time frame: from study enrollment until progression or death for any cause, up to 7 years

    To identify emerging gene alterations associated with Progression Free Survival (PFS) defined as the time from study enrollment until progression or death for any cause, whichever comes first

  2. To identify emerging gene alterations associated with Overall Survival

    Time frame: from study enrollment until death for any cause, up to 7 years

    To identify emerging gene alterations associated with Overall Survival, defined as the time from study enrollment until death for any cause

  3. To describe changes in ctDNA associated biomarkers during treatment

    Time frame: up to 7 years

    Difference in frequency of patients with ctDNA associated biomarkers at different time point during treatment (at baseline, at start of cycle 2, at first radiological evaluation, at relapse or end of follow-up)

  4. To evaluate the association between somatic genetic alterations and the histopathological features of the tumor

    Time frame: up to 7 years

    Frequency of somatic genetic alterations in subgroups of patients with different histopathological tumor characteristics

  5. To evaluate the association between somatic genetic alterations and pattern of metastasis

    Time frame: up to 7 years

    Frequency of somatic genetic alterations in subgroups of patients with metastasis

  6. To evaluate the association between somatic genetic alterations and the clinical characteristic of the enrolled patients

    Time frame: up to 7 years

    Frequency of somatic genetic alterations in subgroups of patients with different clinical characteristics

Study contacts

Contact information is provided by the study sponsor or research team.

Fabio Puglisi, MD, PhD

CONTACT

[email protected]

0434659253

Giulia Cudia, MSc

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Centro di Riferimento Oncologico - Aviano

Other

Registry information

Official study title

A Prospective, Observational Study on the Prevalence of Clinically Useful Mutations in Solid Tumor Characterized by Next Generation Sequencing Methods on Liquid Biopsy Analysis (POPCORN)

Acronym: POPCORN

Important dates

Study start
2023
Primary completion
2030
Study completion
2030
First posted
Sep 8, 2023
Registry last updated
Sep 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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