Trial Title:
Circulating Tumour DNA and Urine Tumor DNA Detection of Minimal Residual Disease in Locally Advanced Upper Tract Urothelial Carcinoma With Radical Nephroureterectomy: A Cohort Study
NCT ID:
NCT05595408
Condition:
Muscle Invasive Upper Tract Urothelial Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Transitional Cell
Neoplasm, Residual
Immunomodulating Agents
Conditions: Keywords:
upper tract urothelial carcinoma
Minimal residual disease
Circulating tumor DNA
Urine tumor DNA
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Drug
Intervention name:
Adjuvant chemotherapy
Description:
cisplatin/carboplatin-gemcitabine 4-6 cycles
Arm group label:
adjuvant chemotherapy group
Intervention type:
Drug
Intervention name:
adjuvant immunotherapy
Description:
immunotherapy for one year
Arm group label:
adjuvant immunotherapy group
Summary:
In our study, the ultra-deep sequencing of circulating tumor DNA (ctDNA) and urine tumor
DNA (utDNA) were performed to assess whether ctDNA and utDNA can be used as predictive
biomarkers for the detection of minimal residual disease (MRD) and early diagnosis of
UTUC recurrence, and explored the role of ctDNA and utDNA detection of MRD in the
prediction of adjuvant therapy efficacy and prognostic evaluation.
Detailed description:
60% of Upper Urinary Tract Urothelial Carcinoma (UTUC) patients with muscle-invasive
disease at diagnosis, which progresses rapidly, aggressively, and has a poor prognosis.
Up to 30-40% of the patients may develop bladder recurrance after radical
nephroureterectomy for primary upper tract urothelial carcinoma.
Minimal residual disease (MRD) refers to the small number of malignant cells that remain
after curative treatments (curative intent surgical resection, radiotherapy, and/or
chemotherapy). MRD is common in patients with blood cancer, and is known to be associated
with recurrence and poor prognosis. Recent studies also reported that MRD-negative in
postoperative solid tumors such as colorectal/colon cancer and muscle-invasive bladder
cancer is associated with better survival outcomes. However, the clinical values of MRD
monitoring for adjuvant therapy in postoperative UTUC remain inadequate.
A total of 103 patients with stage II-IV UTUC will be recruited in this clinical trial.
The following plasma samples, urine samples and tumor tissues will be collected from each
patient including 1) preoperative plasma and urine samples; 2) surgical tissue samples;
3) plasma and urine samples 1 month after surgery; 4) plasma and urine samples during
adjuvant therapy; and 5) plasma and urine samples after adjuvant therapy; 6) plasma and
urine samples in follow-up. In addition, demographic and tumor characteristics of the
patients will be collected for subsequent analysis, including age, sex, tumor stage,
pathological stage, disease couse time, etc. Tumor tissues and matched peripheral blood
were collected before treatment and WES was used ctDNA detection techniques. For each
patient, we selected up to 30 clonal somatic mutations for personalized, tumor informed
ctDNA assay design.Statistical analyses will be performed to analyze the survival
outcomes and to explore the clinical value of MRD monitoring for adjuvant therapy in
postoperative UTUC.
Criteria for eligibility:
Study pop:
pathological comfirmed T2-4 or N+ and M0 upper tract urothelial carcinoma patients who
received adjuvant chemotherapy or immunotherapy after radical nephroureterectomy
Sampling method:
Probability Sample
Criteria:
Inclusion Criteria:
- pathological comfirmed T2-4 or N+ and M0 upper tract urothelial carcinoma
- Male or female aged ≥18 years old who are willing to sign the informed consent form
- have no distant metastasis
- have an ECOG 0 to 2
- upper tract urothelial carcinoma patients received radical nephroureterectomy
- have no multiple primary carcinoma received adjuvant chemotherapy or immunotherapy
after surgery
Exclusion Criteria:
- • a prior history of bladder or synchronous bladder cancer
- Pregnant or lactating women, or patients who are fertile but do not take
contraceptive measures;
- Severe infection;
- Severe heart disease;
- Uncontrollable neurological or mental disorders;
- Severe diabetes mellitus;
- Patients with severe autoimmune diseases.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Renji Hospital
Address:
City:
Shanghai
Zip:
200127
Country:
China
Status:
Recruiting
Contact:
Last name:
jiwei huang, M.D
Phone:
8621-68383716
Email:
huangjiwei@renji.com
Start date:
February 1, 2022
Completion date:
December 31, 2024
Lead sponsor:
Agency:
RenJi Hospital
Agency class:
Other
Collaborator:
Agency:
Ruijin Hospital
Agency class:
Other
Collaborator:
Agency:
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Agency class:
Other
Collaborator:
Agency:
Fudan University
Agency class:
Other
Collaborator:
Agency:
West China Hospital
Agency class:
Other
Collaborator:
Agency:
Xiangya Hospital of Central South University
Agency class:
Other
Collaborator:
Agency:
Peking University First Hospital
Agency class:
Other
Collaborator:
Agency:
Shanghai 10th People's Hospital
Agency class:
Other
Collaborator:
Agency:
The Second Affiliated Hospital of Dalian Medical University
Agency class:
Other
Collaborator:
Agency:
First Affiliated Hospital Xi'an Jiaotong University
Agency class:
Other
Collaborator:
Agency:
The First Affiliated Hospital of Soochow University
Agency class:
Other
Collaborator:
Agency:
Tianjin Medical University Second Hospital
Agency class:
Other
Collaborator:
Agency:
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology
Agency class:
Other
Collaborator:
Agency:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Agency class:
Other
Collaborator:
Agency:
The Affiliated Hospital of Medical School of Ningbo University
Agency class:
Other
Collaborator:
Agency:
Yantai Yuhuangding Hospital
Agency class:
Other
Collaborator:
Agency:
Nanjing Medical University Affiliated Cancer Hospital
Agency class:
Other
Collaborator:
Agency:
Zhejiang University
Agency class:
Other
Collaborator:
Agency:
Lihuili Hospital
Agency class:
Other
Collaborator:
Agency:
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Agency class:
Other
Collaborator:
Agency:
Zhongda Hospital
Agency class:
Other
Source:
RenJi Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05595408
