Clinical trial NCT06140992: PaCIFiC-CUP Classifies Cancer of Unknown Primary
Official title: PaCIFiC-CUP：Pan-Cancer Integrated Fingerprinting Classifier for Identifying the Origin of Cancer of Unknown Primary: A Multi-Center Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Unknown Primary Tumors
DNA Methylation
Keywords: Unknown Primary Tumors
DNA methylation
Large Language Model
Pan-cancer
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: First People's Hospital of Foshan
name: Third Affiliated Hospital, Sun Yat-Sen University
name: The First Affiliated Hospital of Anhui Medical University
name: Anhui Provincial Cancer Hospital
name: Dongguan People's Hospital
name: Beijing Tongren Hospital
name: Anhui Provincial Hospital
name: Peking University Third Hospital
name: Henan Cancer Hospital
name: Ganzhou Cancer Hospital
name: Guangzhou Chest Hospital.
name: First Affiliated Hospital of Jinan University
name: Peking University Shenzhen Hospital
name: Affiliated Cancer Hospital & Institute of Guangzhou Medical University
First posted: 2023-11-21
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population consists of patients diagnosed with CUP who meet the inclusion and exclusion criteria.

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.


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.

Primary outcomes:
measure: Overall Survival
timeFrame: From date of diagnosis until the date of death from any cause, assessed up to 24 months
Secondary outcomes:
measure: Progression-Free Survival
timeFrame: 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
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen university cancer center
state: Guangdong
Study officials:
References:
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