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Neoplasms, Unknown Primary clinical trials

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NCT ID: NCT06140992 Recruiting - DNA Methylation Clinical Trials

PaCIFiC-CUP Classifies Cancer of Unknown Primary

Start date: July 1, 2023
Phase:
Study type: Observational

This study aims to initially utilize machine learning on pan-cancer DNA methylation data from public databases to construct a DNA methylation classification model (PaCIFiC-CUP, pan-cancer integrated fingerprinting classifier of CUP) for diagnosing various types of cancer, particularly the primary site of cancer of unknown primary. The goal is to achieve diagnosis of cancer pathology type by analyzing the DNA methylation patterns of cancer specimens, thereby guiding subsequent precision treatment for cancer.

NCT ID: NCT06100081 Recruiting - Oropharynx Cancer Clinical Trials

Real-time Targeted Fluorescence Endoscopy for Detection of the Primary Cancer Lesion in Patients With a Metastasis of Unknown Primary Tumor in the Head and Neck

REFLECT
Start date: April 28, 2023
Phase: N/A
Study type: Interventional

In current diagnostic work-up of patients with a cancer of unknown primary (CUP), approximately 50% of the primary tumor lesions remains undetected. Identification of the primary tumor site results in minimizing the potential morbidity from treatment by reducing morbidity by omitting the need for a mucosectomy of the bilateral base of tongue and tonsils, reducing the radiation field and better oncologic outcome than those with unidentified primary tumor. Clearly, new endoscopic 'real-time' imaging techniques are needed to visualize mucosal changes associated with head and neck squamous cell carcinoma and increase detection rate of the primary tumor. Targeted fluorescence endoscopy enables the visualization of targeted tumor-specific biomarkers by using fluorescence, thereby enhancing the contrast between normal mucosa and tumor tissue. This could improve the detection of the primary tumor in cases where the primary tumor is not detected with white light endoscopy.

NCT ID: NCT05841966 Completed - Clinical trials for Cancer of Unknown Primary Site

Surgeon-performed Intraoperative Transoral Ultrasound for Cancer of Unknown Primary

OP-CUP
Start date: February 21, 2023
Phase: N/A
Study type: Interventional

Adult patients suspected of Squamous Cell Carcinoma of Unknown Primary (SCCUP) will be prospectively enrolled at a tertiary head & neck cancer center at Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark. All patients will undergo Magnetic Resonance Imaging (MRI) and Positron Emission Tomography-Computerized Tomography (PET-CT) prior to examination in general anesthesia. During general anesthesia, Intraoperative Transoral Ultrasound (ITUS) will be performed prior to panendoscopy. Detected tumors will be registered with specified oropharyngeal sub-locations. Blinded to ITUS, a consultant head & neck surgeon will perform panendoscopy. After examination, the surgeon is unblinded to ultrasound results. Final histopathology results from location-specified biopsies performed will be used as reference standard. The overall detection rate will be compared between ITUS, panendoscopy, PET-CT and MRI with sensitivity and specificity analysis. Oropharynx sub-location specific detection rate of ITUS vs. panendoscopy will be compared with logistic regression analysis.

NCT ID: NCT05576974 Recruiting - Clinical trials for Head and Neck Cancer

A Phase 2a, Single-dose, Open-label Study to Evaluate Diagnostic Performance and Safety of Pegsitacianine, an Intraoperative Fluorescence Imaging Agent for the Detection of Cancer, in Patients With Unknown Primary Head and Neck Cancer (ILLUMINATE STUDY)

Start date: April 17, 2024
Phase: Phase 2
Study type: Interventional

This is a non-randomized, open-label, single-center, safety and imaging feasibility study of Pegsitacianine, an intraoperative fluorescence imaging agent.

NCT ID: NCT05263700 Recruiting - Clinical trials for Cancer of Unknown Primary Site

FAPI-CUP- Evaluating FAPI as a Novel Radiopharmaceutical for Cancer of Unknown Primary

FAPI-CUP
Start date: February 23, 2022
Phase: N/A
Study type: Interventional

This is a prospective single arm cohort study designed to evaluate the diagnostic ability of 68Ga-FAPI-PET/CT scan in determining likely tissue of origin in Cancer of Unknown Primary (CUP) patients not identified by standard of care. Patients with CUP will be either treatment naïve or starting second-line treatment.

NCT ID: NCT05241132 Recruiting - Chemotherapy Effect Clinical Trials

Tislelizumab Combined With Chemotherapy in the Treatment of Bone Metastases of Unknown Primary

Start date: November 12, 2021
Phase: Phase 2
Study type: Interventional

Through scientific and rigorous design, implementation, follow-up and statistics, the sponsor aims to explore the clinical efficacy and safety of Tislelizumab combined with chemotherapy (platinum + paclitaxel) in the treatment of patients with bone metastases cancer with unknown primary, and provide a better treatment plan for these patients. 1. Primary outcome: Objective response rate (ORR) 2. Secondary outcomes: disease control rate (DCR), duration of remission (DOR), progression-free disease (PFS), overall survival (OS), median PFS, median OS, stratification based on clinical features and PD-L1 expression, adverse reactions (AEs), and quality of life.

NCT ID: NCT05046444 Recruiting - Leukemia Clinical Trials

Solving Riddles Through Sequencing

SIRIUS
Start date: January 19, 2022
Phase:
Study type: Observational

During the last decades hematologists have excelled at improving and refining the classification, diagnosis, and thus ultimately the therapeutic decision-making process for their patients. This continuous evolution proceeded in parallel to seminal discoveries in basic science such as FISH, PCR and NGS. So far, the current WHO classification serves as reference to diagnostic decision making and is largely based on 5 diagnostic pillars: cytomorphology of peripheral blood and/or bone marrow smears, histology and immunohistochemistry of bone marrow trephine biopsies or lymph nodes, immunophenotyping, chromosome banding analysis supplemented by FISH analysis, molecular genetics including PCR and targeted panel sequencing via NGS. This leads to a swift diagnosis in 90 % of all cases. The leftover 10 % remain a challenge for hematopathologists and clinicians alike and are resolved through interdisciplinary teams in the context of specialized boards. With the advent of high throughput sequencing (mainly WGS and WTS) the possibility of a comprehensive and detailed portrait of the genetic alterations - specifically in challenging cases - has become a realistic alternative to classical methods. In SIRIUS the investigators will prospectively challenge this hypothesis to address the question of how often a better or final diagnosis can be delivered by WGS and/or WTS and if unclear cases can be efficiently resolved.

NCT ID: NCT05024968 Active, not recruiting - Clinical trials for Cancer of Unknown Primary Site

Sintilimab in Cancer of Unknown Primary

Start date: August 26, 2021
Phase: Phase 2
Study type: Interventional

This is a Phase 2 clinical trial evaluating the efficacy and safety of sintilimab in subjects with CUP. Up to 45 subjects with CUP will be enrolled. Subjects will be treated with sintilimab at 200 mg via intravenous (IV) administration on Cycle 1 Day 1. The treatment will repeat every 3 weeks until progressive disease (PD), intolerable toxicity, initiation of new anti-tumor therapy, withdrawal of consent, lost to follow-up, death, completion of therapy, or any other investigator-determined reasons for treatment discontinuation (whichever occurs first). Treatment will continue for a maximum period of 24 months (starting from the first dose). During the trial, tumor imaging evaluation will be initially performed once every 9 weeks (± 7 days) and will be based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. After the completion or discontinuation of the study treatment, safety follow-up and survival follow-up will be performed. Considering the rareness of the disease, the patient accrual rate is expected to be approximately 2 patients per month. The total study duration is expected to be between 24-27 months with 6-month follow up.

NCT ID: NCT04969835 Recruiting - Breast Cancer Clinical Trials

A Study Evaluating the Safety, Pharmacokinetics and Early Efficacy of AVA6000 in Solid Tumours

Start date: July 16, 2021
Phase: Phase 1
Study type: Interventional

This open-label, First-into-Human (FIH) study will evaluate the safety, tolerability, pharmacokinetics (PK) and early efficacy of AVA6000, a FAP-activated pro-drug of doxorubicin, in patients with locally advanced and/or metastatic solid tumours. In Phase Ia, using a 3+3 design, escalating doses of AVA6000 will be administered to patients with a range of solid tumour types to determine the maximum tolerated dose (MTD) and/or recommended Phase II dose (RP2D). In Phase 1b, the selected RP2D dose will be assessed in one to three tumour types.

NCT ID: NCT04952103 Recruiting - Clinical trials for Cancer of Unknown Primary Site

Real World Study of Diagnosis and First-line Treatment Among Patients With Cancer of Unknown Primary in China

Start date: June 18, 2021
Phase:
Study type: Observational

This study is a prospective, real world study.The objective is to observe the diagnosis and first-line treatment of Chinese patients with cancer of unknown primary, and collect the clinicopathological characteristics, treatment outcomes, survival and other data of the patients.