PaCIFiC-CUP Classifies Cancer of Unknown Primary
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorSun Yat-sen University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
The patient specimens were obtained from the Sun Yat-sen University Cancer Center and affiliated cooperating centers, with written consent from the patients authorizing the use of the specimens for research purposes.
Following standard assessments (medical history, physical examination, complete blood count, biochemistry, computed tomography scans of the neck, chest, abdomen, and pelvis, targeted evaluations of all symptomatic areas, pathology, and immunohistochemistry), the diagnosis was determined as a primary site unknown tumor (including adenocarcinoma, squamous cell carcinoma, undifferentiated carcinoma, neuroendocrine carcinoma, sarcoma, etc).
The diagnosis was confirmed at the participating institution and the patient had received systemic therapy.
Complete clinical, pathological, and follow-up data for the patients can be obtained.
Disqualifiers
Pregnant or lactating female patients.
Tumor tissue sample size is too small (tumor tissue accounts for <70% in the biopsy or slice tissue).
Organ transplant or history of non-autologous (allogeneic) bone marrow or stem cell transplantation.
History of previous tumors, with the current condition being a recurrent tumor.
Trial population
The study population consists of patients diagnosed with CUP who meet the inclusion and exclusion criteria.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
120 Participants
are grouped into 2 trial groupsGroup A: Site-Specific Therapy Group
Group B: Empirical Therapy Group
Trial outcomes
Primary outcomes
1
Overall Survival
Overall survival refers to the length of time that a person lives after being diagnosed with cancer of unknown primary, without regard to any specific cause of death.
Time frame
From date of diagnosis until the date of death from any cause, assessed up to 24 monthsSecondary outcomes
1
Progression-Free Survival
Progression-Free Survival refers to the length of time during which a patient with cancer of unknown primary remains alive without any signs or symptoms of disease progression
Time frame
From date of diagnosis until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Sun Yat-sen University
Lead sponsor
First People's Hospital of Foshan
Collaborator
Third Affiliated Hospital, Sun Yat-Sen University
Collaborator
The First Affiliated Hospital of Anhui Medical University
Collaborator
Anhui Provincial Cancer Hospital
Collaborator
Dongguan People's Hospital
Collaborator
Beijing Tongren Hospital
Collaborator
Anhui Provincial Hospital
Collaborator
Peking University Third Hospital
Collaborator
Henan Cancer Hospital
Collaborator
Ganzhou Cancer Hospital
Collaborator
Guangzhou Chest Hospital.
Collaborator
First Affiliated Hospital of Jinan University
Collaborator
Peking University Shenzhen Hospital
Collaborator
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Collaborator
Source ClinicalTrials.gov