PaCIFiC-CUP Classifies Cancer of Unknown Primary

Sponsor
Sun Yat-sen University (Other)
Overall Status
Recruiting
CT.gov ID
NCT06140992
Collaborator
First People's Hospital of Foshan (Other), Third Affiliated Hospital, Sun Yat-Sen University (Other), The First Affiliated Hospital of Anhui Medical University (Other), Anhui Provincial Cancer Hospital (Other), Dongguan People's Hospital (Other), Beijing Tongren Hospital (Other), Anhui Provincial Hospital (Other), Peking University Third Hospital (Other), Henan Cancer Hospital (Other), Ganzhou Cancer Hospital (Other), Guangzhou Chest Hospital. (Other), First Affiliated Hospital of Jinan University (Other), Peking University Shenzhen Hospital (Other), Affiliated Cancer Hospital & Institute of Guangzhou Medical University (Other)
160
1
30
5.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    160 participants
    Observational Model:
    Cohort
    Time Perspective:
    Cross-Sectional
    Official Title:
    PaCIFiC-CUP:Pan-Cancer Integrated Fingerprinting Classifier for Identifying the Origin of Cancer of Unknown Primary: A Multi-Center Bidirectional Cohort Study
    Actual Study Start Date :
    Jul 1, 2023
    Anticipated Primary Completion Date :
    Dec 31, 2025
    Anticipated Study Completion Date :
    Dec 31, 2025

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

    1. Overall Survival [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.

    Secondary Outcome Measures

    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]

      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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sun Yat-sen university cancer center Guangzhou Guangdong China 510060

    Sponsors and Collaborators

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

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Xiao-Peng Tian, Principal Investigator, Sun Yat-sen University
    ClinicalTrials.gov Identifier:
    NCT06140992
    Other Study ID Numbers:
    • PaCIFiC-CUP
    First Posted:
    Nov 21, 2023
    Last Update Posted:
    Nov 21, 2023
    Last Verified:
    Nov 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Xiao-Peng Tian, Principal Investigator, Sun Yat-sen University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 21, 2023