A Study of Individualized Radiotherapy Based on a Predict... | NCT03416803

Studies
A Study of Individualized Radiotherapy Based on a Prediction Model of Lymph Node Metastasis in Hepatocellular Carcinoma

NCT03416803

Sponsor

Shanghai Zhongshan Hospital

Status

Unknown status

Last Update Posted

Feb 5, 2018Actual

Enrollment

150Estimated

Phase

Not Applicable

Conditions

Lymph Node Metastasis
Hepatocellular Carcinoma
Radiotherapy

Interventions

Radiotherapy

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2018Estimated

Primary Completion Date

Dec 31, 2019Estimated

Completion Date

Jun 30, 2020Estimated

First Submitted Date

Jan 8, 2018

First Submission Date that Met QC Criteria

Jan 24, 2018

First Posted Date

Jan 31, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 1, 2018

Last Update Posted Date

Feb 5, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Objectives:

To further validate the predictive efficacy of our established microRNA prediction model of HCC lymph node metastasis.
To establish a precise therapeutic mode of prophylactic radiation therapy in high-risk patients with HCC with lymph node metastasis under the guidance of a microRNA prediction model.

Detailed Description

First, screening out patients who underwent hepatic tumor resection and pathologically diagnosed as HCC .

Then，performing the detection of miR-145, miR-31 and miR-92a by using the HCC lymph node metastasis microRNA correlation prediction model established in our previous study. The patients are judged as high risk of lymph node metastasis and low risk Patients, then high-risk patients under the condition of informed consent into the group, randomized into treatment group and control groups.

Last, Patients enrolled in the treatment group were treated with radiotherapy and followed up.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

150Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Radiotherapy	Experimental	Patients in the experimental group, who were at high risk for lymph node metastasis, underwent radiotherapy in the lymphatic drainage area. Radiotherapy was started in lymphatic drainage areas about 1 month after HCC surgery. The range of radiotherapy was hepatic portal area, pancreas circumference, celiac trunk and abdomen Around the aortic lymph drainage area, the dose of radiation 45Gy, conventional segmentation.	Radiation: Radiotherapy
Blank control	No Intervention	Patients in the control group , who were at high risk for lymph node metastasis，were followed up.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Radiotherapy	Radiation	Radiotherapy	Radiotherapy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
2-year overall survival	The therapeutic effects are mainly evaluated by the 2-year overall survival.	The outcome measures are assessed up to 2 years.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients underwent liver tumor resection and pathological diagnosis of HCC in our hospital.
The tumor samples of these HCC patients were detected by in situ hybridization with miR-145, miR-31 and miR-92a. We used the previously established HCC lymph node metastasis microRNA prediction model to determine the patients with high-risk lymph node metastasis and low-risk patients at high risk Patients were randomly assigned into treatment group and control group with informed consent.
HCC patients were not receive other anti-cancer treatment.
Blood routine examination was normal.
Child-Pugh grade A, normal liver and kidney function in the normal range (including ALT or ASL within 2.5 times the normal), WBC> 3 × 109 / L, Hb> 90g / L, PLT> 50 × 109 /
HCC patients were not receive the history of upper abdominal radiotherapy.
sign the informed consent.
age 18-75 years old.
KPS score 80-100 points.

Exclusion Criteria:

accepted other anti-cancer treatment.
Patients was determined to be low-risk lymph node metastasis by the pre-established HCC lymph node metastasis microRNA prediction model.
blood and liver and kidney dysfunction.
can not control the infection.
at the same time the merger of other malignant tumors.
while using other experimental drugs or to participate in other clinical trials.
serious heart, lung, kidney disease.
pregnant or lactating women.
serious nervous system disease, can not clearly tell the treatment

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Zhaochong Zeng, Phd	Contact	13817076800		zeng.zhaochong@zs-hospital.sh.cn
Zuolin Xiang, Phd	Contact	13701816716		xiangzuolinmd@hotmail.com

Overall Officials

Name	Affiliation	Role
Zhongshan Hospital, PhD	Fudan University, Shanghai,China	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
180 Fenglin Road	Recruiting	Shanghai		200032	China

ID	Term
D008207	Lymphatic Metastasis
D006528	Carcinoma, Hepatocellular

ID	Term
D009362	Neoplasm Metastasis
D009385	Neoplastic Processes
D009369	Neoplasms
D010335	Pathologic Processes