PaCIFiC-CUP Classifies Cancer of Unknown Primary

NCT06140992 | Recruiting

• 1 other identifier: PaCIFiC-CUP
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Unknown Primary Tumors; DNA Methylation

Keywords

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

Outcome Measures

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.

  From date of diagnosis until the date of death from any cause, assessed up to 24 months

Secondary Outcomes (1)

• Progression-Free Survival

  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 months

Study Arms (2)

Site-Specific Therapy Group

These patients with cancer of unknown primary received site-specific therapy that matched the particular site predicted by the DNA methylation classifier.

Empirical Therapy Group

These patients with cancer of unknown primary received empirical therapy that didn't match the particular site predicted by the DNA methylation classifier.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of patients diagnosed with CUP who meet the inclusion and exclusion criteria.

You may qualify if:

• 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.
• ECOG performance status score: 0-2 points.

You may not qualify if:

• 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.
• Hematological malignancies (excluding lymphoma).
• Other diseases that may severely impact patient survival, such as severe cardiovascular or cerebrovascular diseases, sepsis, severe trauma or burns, etc.

Sponsors & Collaborators

• Sun Yat-sen University: lead
• 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

Study Sites (1)

Sun Yat-sen university cancer center

Guangzhou, Guangdong, 510060, China

RECRUITING

Related Publications (16)

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MeSH Terms

Conditions

Neoplasms, Unknown Primary

Condition Hierarchy (Ancestors)

Neoplasm Metastasis; Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Yiyang Zhang

CONTACT

+8615652797092; zhangyy@sysucc.org.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 14, 2023
• First Posted: November 21, 2023
• Study Start: July 1, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)