Clinical trial NCT06232538: UCAD for Diagnosing Benign or Malignant Gallbladder Diseases and Follow-up
Official title: A Prospective, Multi-centre, Single-blinded Study of UCAD for Diagnosing Benign or Malignant Gallbladder Diseases and Follow-up
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Gallbladder Cancer
Keywords: diagnosis
Lead sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
Collaborators: name: Shanghai Zhongshan Hospital
name: Ruijin Hospital
name: Changhai Hospital
name: Shanghai Changzheng Hospital
name: Eastern Hepatobiliary Surgery Hospital
name: First Affiliated Hospital Xi'an Jiaotong University
name: Jiangsu Provincial People's Hospital
name: Third Affiliated Hospital, Sun Yat-Sen University
name: First Affiliated Hospital of Zhejiang University
name: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
name: Second Hospital of Jilin University
name: West China Hospital
name: Southwest Hospital, China
name: Afﬁliated Hospital of North Sichuan Medical College
name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
First posted: 2024-01-30
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with malignant biliary obstruction or participants in control group from February 2022 till the end of this study in 11 hospitals including Xinhua Hospital, Shanghai Zhongshan Hospital, Ruijin Hospital, Changhai Hospital, Shanghai Changzheng Hospital, Eastern Hepatobiliary Surgery Hospital, The First Affiliated Hospital of Xi'an Jiaotong University, Jiangsu Provincial Hospital, The Third Affiliated Hospital of Sun Yat-Sen University, Tianjin Medical University Second Hospital, First Affiliated Hospital of Zhejiang University

Brief summary: Copy number variation(CNV) refers to ongoing chromosome segregation errors throughout consecutive cell divisions. CNV is a hallmark of human cancer, and it is associated with poor prognosis, metastasis, and therapeutic resistance. Analyzing CNV of the DNA extracted from bile samples in gallbladder seems a promising method for diagnosing, monitoring, and predicting the prognosis of patients with gallbladder cancer. CNV can be assessed using experimental techniques such as bulk DNA sequencing, fluorescence in situ hybridization (FISH), or conventional karyotyping. However, these techniques are either time-consuming or non-specific. The investigators here intend to study whether a new method named Ultrasensitive Chromosomal Aneuploidy Detection (UCAD), which is based on low-coverage whole-genome sequencing, can be used to analyze CNV thus helping diagnose gallbladder cancer and assessing follow-up.


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with gallbladder disease and planned to undergo surgery.
* Male or female patients aged \>= 18 years.
* Participants signed informed consent form.

Exclusion Criteria:

* Participants had other tumor expect gallbladder cancer

Primary outcomes:
measure: UCAD can be used as a diagnostic technology for gallbladder cancer with the sensitivity more than 90%
timeFrame: 2025
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Xinhua Hospital
state: Shanghai
Study officials:
References:
citation: Hieronymus H, Murali R, Tin A, Yadav K, Abida W, Moller H, Berney D, Scher H, Carver B, Scardino P, Schultz N, Taylor B, Vickers A, Cuzick J, Sawyers CL. Tumor copy number alteration burden is a pan-cancer prognostic factor associated with recurrence and death. Elife. 2018 Sep 4;7:e37294. doi: 10.7554/eLife.37294.