Study on the mechanism of CDC73/RNF20-mediated H2B monoubiquitination modification to alleviate paclitaxel resistance in esophageal cancer

Registration number:

ITMCTR2024000655

Date of Last Refreshed on:

2024-11-05

Date of Registration:

2024-11-05

Registration Status:

Prospective registration

Public title:

Study on the mechanism of CDC73/RNF20-mediated H2B monoubiquitination modification to alleviate paclitaxel resistance in esophageal cancer

English Acronym:

Scientific title:

Study on the mechanism of CDC73/RNF20-mediated H2B monoubiquitination modification to alleviate paclitaxel resistance in esophageal cancer

Scientific title acronym:

Study subject ID:

The registration number of the Partner Registry or other register:

Applicant:

songjie

Study leader:

songjie

Applicant telephone:

13566391189

Study leader's telephone:

13566391189

Applicant Fax:

Study leader's fax:

Applicant E-mail:

349809596@qq.com

Study leader's E-mail:

349809596@qq.com

Study leader's website(voluntary supply):

Study leader's website
(voluntary supply):

Applicant address:

No. 57 Xingning Road Ningbo City

Study leader's address:

No. 57 Xingning Road Ningbo City

Applicant postcode:

Study leader's postcode:

Applicant's institution:

Ningbo Medical Center Li Huili Hospital

Approved by ethic committee:

Approved No. of ethic committee:

KY2023SL303-01

Approved file of Ethical Committee:

View

Name of the ethic committee:

Medical Ethics Committee of Li Huili Hospital, Ningbo Medical Center

Date of approved by ethic committee:

2023/11/27 0:00:00

Contact Name of the ethic committee:

Zhang Pei

Contact Address of the ethic committee:

No. 57 Xingning Road Ningbo City

Contact phone of the ethic committee:

0574-87018834

Contact email of the ethic committee:

lihuiliethics@163.com

Primary sponsor:

Ningbo Medical Center Li Huili Hospital

Primary sponsor's address:

No. 57 Xingning Road Ningbo City

Secondary sponsor:

Country:

CHINA

Province:

zhejiang

City:

Ningbo

Institution
hospital:

Ningbo Medical Center Li Huili Hospital

Address:

No. 57 Xingning Road Ningbo City

Source(s) of funding:

Zhejiang Traditional Chinese Medicine Administration

Target disease:

esophageal cancer

Target disease code:

Study type:

Interventional study

Study design:

Non randomized control

Study phase:

Others

Objectives of Study:

To analyze the expression of CDC73/RNF20 in esophageal cancer patient tissues and paclitaxel-resistant cell lines, and to analyze the correlation between CDC73/RNF20 and the prognosis of esophageal cancer patients. To elucidate the mechanism of maintaining paclitaxel resistance in esophageal cancer through CDC73/RNF20-mediated H2B monoubiquitination modification. Combined with proteome sequencing technology, the downstream mechanism of intracellular H2B monoubiquitination modification of paclitaxel resistant cells in esophageal cancer was analyzed. To clarify the effect and mechanism of Qijisan on the chemotherapy effect of paclitaxel in esophageal cancer through CDC73/RNF20.

Description for medicine or protocol of treatment in detail:

Inclusion criteria

Patients with a clinical diagnosis of esophageal cancer

Exclusion criteria:

1: 1) Severe cardiovascular disease that cannot tolerate laparoscopic surgery 2: 2) acute inflammatory phase 3: 3) Preoperative suspicion of other malignant tumors or distant metastases of malignant tumors

Study execute time:

From 2025-01-01

To      2025-12-30

Recruiting time:

From 2025-01-01

To      2025-12-30

Interventions:

25

Group:

No Chinese medicine group

Sample size:

Intervention:

The non-TCM group was not treated with Qi Diaphragm.

Intervention code:

25

Group:

Qidiaphan group

Sample size:

Intervention:

The Qidiaphan group was given 1 dose per day, divided into morning and evening, 14 days as a course of treatment, a total of 3 courses of treatment.

Intervention code:

Total sample size : 50

Countries of recruitment
and research settings:

Country:

CHINA

Province:

zhejiang

City:

Ningbo

Institution/hospital:

Ningbo Medical Center Li Huili Hospital

Level of the institution:

Tertiary A hospital

Outcomes:

Outcome:

The expression level of CDC73 in blood samples of esophageal cancer patients was detected by RT-qPCR

Type:

Primary indicator

Measure time point of outcome:

2025.12.30

Measure method:

RT-qPCR

Collecting sample(s)
from participants:

Sample Name:

blood

Tissue:

Fate of sample 

Destruction after use

Note:

Not yet recruiting

18
Min age years
70
Max age years

Recruiting status:

Participant age:

Gender:

Both

Randomization Procedure (please state who generates the random number sequence and by what method):

Non-random

Blinding:

IPD sharing:

Yes

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url):

Disclosure after the completion of the trial; Date of publication of raw data: expected early July 2027; Public inquiry: It is managed by the public platform for clinical trials

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture:

The paper version of the original data record and case record form is kept by the person in charge of the experiment, and the electronic version is entered and stored by the EDC system

Data Managemen Committee:

Yes

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

Publication of academic papers

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