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NCT Number: NCT06140992

PaCIFiC-CUP Classifies Cancer of Unknown Primary

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Sun Yat-sen university cancer center

Guangzhou, Guangdong, 510060, China

Location status: Recruiting

Location contact

Yiyang Zhang

CONTACT

[email protected]

+8615652797092

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Yiyang Zhang

CONTACT

[email protected]

+8615652797092

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Nov 21, 2023
Registry last updated
Apr 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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