PaCIFiC-CUP Classifies Cancer of Unknown Primary

April 22, 2026 updated by: Xiao-Peng Tian, Sun Yat-sen University

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

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Recruiting
        • Sun Yat-sen University Cancer Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: From date of diagnosis until the date of death from any cause, assessed up to 24 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-Free Survival
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 months
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2023

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

November 14, 2023

First Submitted That Met QC Criteria

November 20, 2023

First Posted (Actual)

November 21, 2023

Study Record Updates

Last Update Posted (Actual)

April 23, 2026

Last Update Submitted That Met QC Criteria

April 22, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PaCIFiC-CUP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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