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PaCIFiC-CUP Classifies Cancer of Unknown Primary

PaCIFiC-CUP:Pan-Cancer Integrated Fingerprinting Classifier for Identifying the Origin of Cancer of Unknown Primary: A Multi-Center Prospective Cohort Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06140992
Enrollment
120
Registered
2023-11-21
Start date
2023-07-01
Completion date
2026-12-31
Last updated
2026-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

DNA Methylation, Unknown Primary Tumors

Keywords

Unknown Primary Tumors, DNA methylation, Large Language Model, Pan-cancer

Brief 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.

Interventions

None listed

Sponsors

Sun Yat-sen University
Lead SponsorOTHER
First People's Hospital of Foshan
CollaboratorOTHER
Third Affiliated Hospital, Sun Yat-Sen University
CollaboratorOTHER
The First Affiliated Hospital of Anhui Medical University
CollaboratorOTHER
Anhui Provincial Cancer Hospital
CollaboratorOTHER
Dongguan People's Hospital
CollaboratorOTHER_GOV
Beijing Tongren Hospital
CollaboratorOTHER
Anhui Provincial Hospital
CollaboratorOTHER_GOV
Peking University Third Hospital
CollaboratorOTHER
Henan Cancer Hospital
CollaboratorOTHER_GOV
Ganzhou Cancer Hospital
CollaboratorUNKNOWN
Guangzhou Chest Hospital.
CollaboratorOTHER
First Affiliated Hospital of Jinan University
CollaboratorOTHER
Peking University Shenzhen Hospital
CollaboratorOTHER
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
CollaboratorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Overall SurvivalFrom date of diagnosis until the date of death from any cause, assessed up to 24 monthsOverall 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.

Secondary

MeasureTime frameDescription
Progression-Free SurvivalFrom date of diagnosis until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 monthsProgression-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

Countries

China

Contacts

CONTACTYiyang Zhang
zhangyy@sysucc.org.cn+8615652797092

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 24, 2026