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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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| Measure | Description | Time Frame |
|---|---|---|
| Real world prevalence of clinically useful mutations in solid tumors | 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. | at the beginning of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| To identify emerging gene alterations associated with Progression Free Survival | 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 | from study enrollment until progression or death for any cause, up to 7 years |
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Inclusion Criteria:
Patients eligible for inclusion in this study have to meet all of the following criteria:
Exclusion Criteria:
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Patients who are receiving therapy for advanced and locally advanced solid tumor as specified in eligibility criteria
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fabio Puglisi, MD, PhD | Contact | 0434659253 | fabio.puglisi@cro.it | |
| Giulia Cudia, MSc | Contact | giulia.cudia@cro.it |
| Name | Affiliation | Role |
|---|---|---|
| Fabio Puglisi, MD, PhD | IRCCS-Centro di Riferimento Oncologico (CRO), Aviano (PN) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS, Centro di Riferimento Oncologico (CRO) di Aviano | Recruiting | Aviano | Pordonone | 33081 | Italy |
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| To identify emerging gene alterations associated with Overall Survival | To identify emerging gene alterations associated with Overall Survival, defined as the time from study enrollment until death for any cause | from study enrollment until death for any cause, up to 7 years |
| To describe changes in ctDNA associated biomarkers during treatment | 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) | up to 7 years |
| To evaluate the association between somatic genetic alterations and the histopathological features of the tumor | Frequency of somatic genetic alterations in subgroups of patients with different histopathological tumor characteristics | up to 7 years |
| To evaluate the association between somatic genetic alterations and pattern of metastasis | Frequency of somatic genetic alterations in subgroups of patients with metastasis | up to 7 years |
| To evaluate the association between somatic genetic alterations and the clinical characteristic of the enrolled patients | Frequency of somatic genetic alterations in subgroups of patients with different clinical characteristics | up to 7 years |
| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| D013274 | Stomach Neoplasms |
| D010190 | Pancreatic Neoplasms |
| D001650 | Bile Duct Neoplasms |
| D006528 | Carcinoma, Hepatocellular |
| D001943 | Breast Neoplasms |
| D010051 | Ovarian Neoplasms |
| D016889 | Endometrial Neoplasms |
| D002583 | Uterine Cervical Neoplasms |
| D014846 | Vulvar Neoplasms |
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D013272 | Stomach Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D001661 | Biliary Tract Neoplasms |
| D001649 | Bile Duct Diseases |
| D001660 | Biliary Tract Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D008113 | Liver Neoplasms |
| D008107 | Liver Diseases |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D014594 | Uterine Neoplasms |
| D014591 | Uterine Diseases |
| D002577 | Uterine Cervical Diseases |
| D014845 | Vulvar Diseases |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
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