PaCIFiC-CUP Classifies Cancer of Unknown Primary

NCT ID: NCT06140992

Last Updated: 2025-06-18

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 120 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-07-01
• Study Completion Date: 2025-12-31

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

First People's Hospital of Foshan

OTHER

Sponsor Role: collaborator

Third Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role: collaborator

The First Affiliated Hospital of Anhui Medical University

OTHER

Sponsor Role: collaborator

Anhui Provincial Cancer Hospital

OTHER

Sponsor Role: collaborator

Dongguan People's Hospital

OTHER_GOV

Sponsor Role: collaborator

Beijing Tongren Hospital

OTHER

Sponsor Role: collaborator

Anhui Provincial Hospital

OTHER_GOV

Sponsor Role: collaborator

Peking University Third Hospital

OTHER

Sponsor Role: collaborator

Henan Cancer Hospital

OTHER_GOV

Sponsor Role: collaborator

Ganzhou Cancer Hospital

UNKNOWN

Sponsor Role: collaborator

Guangzhou Chest Hospital.

UNKNOWN

Sponsor Role: collaborator

First Affiliated Hospital of Jinan University

OTHER

Sponsor Role: collaborator

Peking University Shenzhen Hospital

OTHER

Sponsor Role: collaborator

Affiliated Cancer Hospital & Institute of Guangzhou Medical University

OTHER

Sponsor Role: collaborator

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Xiao-Peng Tian

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Sun Yat-sen university cancer center

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yiyang Zhang

Role: CONTACT

zhangyy@sysucc.org.cn

+8615652797092

Facility Contacts

Yiyang Zhang

Role: primary

zhangyy@sysucc.org.cn

+8615652797092

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Other Identifiers

PaCIFiC-CUP

Identifier Type: -

Identifier Source: org_study_id