Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05918510
Other study ID # RS1647/22
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 4, 2022
Est. completion date April 4, 2029

Study information

Verified date June 2023
Source Regina Elena Cancer Institute
Contact Raul Pellini, Doctor
Phone 06-52664484
Email raul.pellini@ifo.gov.it
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Based on the evidence summarized in the introduction, the clinician hypothesize that the detection of the presence and expression of HPV-DNA, certain miRNAs, and a certain mutational profile in the tissues and biological fluids of these patients, may have important prognostic and diagnostic value not only in HPV-related OPSCCs but also in HPV+ occult T. Accordingly, this study aims to aim to better characterize their potential as biomarkers and to detect the possibility of their their use to implement the sensitivity and specificity of radiological methodologies (PET-CT and MRI), already in use in clinical practice, for monitoring disease progression in this specific subgroup. Finally, by using the collected material to generate organoids and Patient Derived Xenograft (PDX), the study also aims to identify possible new molecular drugs, which could solve the problem of resistance to radiochemotherapy.


Recruitment information / eligibility

Status Recruiting
Enrollment 142
Est. completion date April 4, 2029
Est. primary completion date April 4, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Squamous cell carcinomas of the oropharynx and occult neoplasms with lymph node metastases laterocervical cytologically positive for squamous cell carcinoma treated with TORS or RT or RT/CT - Age > 18 years - ECOG performance status <_ 2 - Ability to follow study procedures and complete questionnaires - Signature of informed consent Exclusion Criteria: - Presence of distant metastases at the time of diagnosis - Previous cancer of the head and neck district - Second tumor in therapy or follow-up for less than 5 years

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Study of Viral BIOmarkers and microRNAs in Tumors Orofarynx
The prospective observational study involves the collection of tissue, blood and saliva samples from OPSCC and occult T patients for detection of HPV-DNA/RNA, miRNA and mutation profile from DNA with centralized analysis of samples at IRCCS Regina Elena National Cancer Institute.

Locations

Country Name City State
Italy "Regina Elena" National Cancer Institute Rome

Sponsors (7)

Lead Sponsor Collaborator
Regina Elena Cancer Institute Azienda Policlinico Umberto I, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Istituto Clinico Humanitas, Istituto Europeo di Oncologia, University of Firenze and Siena, Napoli, Italy, Weizmann Institute of Science

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Accouracy Investigating the kinetics of HPV-DNA and miRNAs in patients with oropharyngeal and occult T tumors with laterocervical metastasis. Conducting this study will allow us to collect the information needed to be able to generate hypotheses and design a subsequent larger study. Baseline
See also
  Status Clinical Trial Phase
Recruiting NCT06065891 - Para-aortic Lymph Node Metastasis in Resectable Pancreatic Cancer N/A
Recruiting NCT06135571 - Study on the No.253 Lymph Node Metastasis Patterns in Left-Sided Colon and Rectal Cancer
Completed NCT06399159 - Prediction of Cervical Lymph Node Metastasis in Papillary Thyroid Carcinoma Based on Ultrasound and Cytological Images
Completed NCT06439745 - More Than 50% of the Patients With Clinically Unifocal T1b/Small T2 Node Negative Papillary Thyroid Carcinoma Scheduled for Thyroid Lobectomy May Require Completion Thyroidectomy if the Nodal Status is Evaluated
Completed NCT00964977 - Effectiveness of Adjuvant Radiotherapy in Small Oropharyngeal Squamous Cell Cancer and Single Lymph Node Metastasis. Phase 3
Completed NCT04233476 - 99mTc-3PRGD2 SPECT/CT for Integrin Imaging of Lung Cancer Phase 3
Enrolling by invitation NCT06048146 - A Prospective, Multicenter Randomized Controlled Study of the Application of Preoperative FOLFOXIRI Chemotherapy Combined With Lateral Lymph Node Dissection in Low- and Medium-lying Rectal Cancer With Lateral Lymph Node Metastasis N/A
Recruiting NCT05720598 - Staging LaParoscopy to Assess Lymph NOde InvoLvement in Advanced GAstric Cancer N/A
Recruiting NCT05970913 - PET-CT Predicting Segement Specific Lymph Nodes Metastasis
Recruiting NCT02142244 - Fluorescence Surgery for Sentinel Node Identification in Melanoma N/A
Enrolling by invitation NCT06273501 - MRI and Magnetometer-guided Sentinel Lymph Node Detection in Vulvar Cancer N/A
Completed NCT02704988 - Clinical Trial Comparing Carnoy's and GEWF Solutions N/A
Completed NCT06401590 - Sensitivity and Predictive Value of Frozen Section of Sentinel Lymph Node Biopsy in Post Neoadjuvant Setting
Not yet recruiting NCT06264167 - NODE (groiN ultrasOunD cancEr) N/A
Recruiting NCT03588416 - Multicentric Study About Pathological Risk Factors for Lymph Node Metastasis in Malignant Colorectal Polyps
Not yet recruiting NCT06435741 - Molecular Imaging of Gastric Cancer Metastatic Lymph Nodes with 99mTc-3PRGD2 Probe. N/A
Recruiting NCT05754814 - SUper-Resolution Ultrasound Imaging of Erythrocytes (SURE) in Normal and Malignant Lymph Nodes
Not yet recruiting NCT05375526 - Magtrial: Magtrace® as Tracer for Sentinel Lymph Node Detection in Early Stage Epithelial Ovarian Cancer N/A
Completed NCT05867095 - Navigated Abdominal Lymph Node Dissections N/A
Not yet recruiting NCT05336643 - Radioisotope and Fluorescence Guidance in Rectal Cancer N/A