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Trial Title:
PaCIFiC-CUP Classifies Cancer of Unknown Primary
NCT ID:
NCT06140992
Condition:
Unknown Primary Tumors
DNA Methylation
Conditions: Official terms:
Neoplasms, Unknown Primary
Conditions: Keywords:
Unknown Primary Tumors
DNA methylation
Large Language Model
Pan-cancer
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Cross-Sectional
Summary:
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.
Criteria for eligibility:
Study pop:
The study population consists of patients diagnosed with CUP who meet the inclusion and
exclusion criteria.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
1. 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.
2. 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).
3. The diagnosis was confirmed at the participating institution and the patient had
received systemic therapy.
4. Complete clinical, pathological, and follow-up data for the patients can be
obtained.
5. ECOG performance status score: 0-2 points.
Exclusion Criteria:
1. Pregnant or lactating female patients.
2. Tumor tissue sample size is too small (tumor tissue accounts for <70% in the biopsy
or slice tissue).
3. Organ transplant or history of non-autologous (allogeneic) bone marrow or stem cell
transplantation.
4. History of previous tumors, with the current condition being a recurrent tumor.
5. Hematological malignancies (excluding lymphoma).
6. Other diseases that may severely impact patient survival, such as severe
cardiovascular or cerebrovascular diseases, sepsis, severe trauma or burns, etc.
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Sun Yat-sen university cancer center
Address:
City:
Guangzhou
Zip:
510060
Country:
China
Status:
Recruiting
Contact:
Last name:
Yiyang Zhang
Phone:
+8615652797092
Email:
zhangyy@sysucc.org.cn
Start date:
July 1, 2023
Completion date:
December 31, 2025
Lead sponsor:
Agency:
Sun Yat-sen University
Agency class:
Other
Collaborator:
Agency:
First People's Hospital of Foshan
Agency class:
Other
Collaborator:
Agency:
Third Affiliated Hospital, Sun Yat-Sen University
Agency class:
Other
Collaborator:
Agency:
The First Affiliated Hospital of Anhui Medical University
Agency class:
Other
Collaborator:
Agency:
Anhui Provincial Cancer Hospital
Agency class:
Other
Collaborator:
Agency:
Dongguan People's Hospital
Agency class:
Other
Collaborator:
Agency:
Beijing Tongren Hospital
Agency class:
Other
Collaborator:
Agency:
Anhui Provincial Hospital
Agency class:
Other
Collaborator:
Agency:
Peking University Third Hospital
Agency class:
Other
Collaborator:
Agency:
Henan Cancer Hospital
Agency class:
Other
Collaborator:
Agency:
Ganzhou Cancer Hospital
Agency class:
Other
Collaborator:
Agency:
Guangzhou Chest Hospital.
Agency class:
Other
Collaborator:
Agency:
First Affiliated Hospital of Jinan University
Agency class:
Other
Collaborator:
Agency:
Peking University Shenzhen Hospital
Agency class:
Other
Collaborator:
Agency:
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Agency class:
Other
Source:
Sun Yat-sen University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06140992
