PaCIFiC-CUP Classifies Cancer of Unknown Primary

Study Overview
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Brief Summary
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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.

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

Conditions
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DNA Methylation, Unknown Primary Tumors

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Site-Specific Therapy Group<br>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<br>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?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-Free Survival | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Unknown Primary Tumors, DNA methylation, Large Language Model, Pan-cancer