TMTP1 Targeting Micro-metastasis LN in Laparoscopic SLN D... | NCT03549195

Studies
TMTP1 Targeting Micro-metastasis LN in Laparoscopic SLN Detection in Cervical Cancer

NCT03549195

Sponsor

Huazhong University of Science and Technology

Status

Unknown status

Last Update Posted

Jun 7, 2018Actual

Enrollment

120Estimated

Phase

Not Applicable

Conditions

Cervical Cancer
Sentinel Lymph Node

Interventions

ICG
ICG-CP
ICG-TMTP1

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

May 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2018Estimated

Primary Completion Date

Jun 1, 2019Estimated

Completion Date

Dec 31, 2019Estimated

First Submitted Date

May 25, 2018

First Submission Date that Met QC Criteria

Jun 6, 2018

First Posted Date

Jun 7, 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

Jun 6, 2018

Last Update Posted Date

Jun 7, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ding Ma, Director, Huazhong University of Science and TechnologyPrincipal Investigator

Lead Sponsor

Huazhong University of Science and TechnologyOTHER

Collaborators

Not provided

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

Investigators aimed to determine the validity of the investigator's novel tumor targeted fluorescent peptide TMTP1-ICG to increased accuracy of laparoscopic SLN mapping

Detailed Description

Not provided

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

120Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ICG	Active Comparator		Procedure: ICG
ICG-CP	Active Comparator	CP, control peptide	Procedure: ICG-CP
ICG-TMTP1	Experimental	also named as TMTP1-ICG	Procedure: ICG-TMTP1

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ICG	Procedure	The ICG powder was diluted and injected into the cervix, divided into 3 and 9 o'clock position, 4 hours before surgery.	ICG

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Detection rate of micro-metastasis sentinel lymph node	Detection of micro-metastasis sentinel lymph node per patient	7 days

Secondary Outcomes

Measure	Description	Time Frame
Sensitivity	Sensitivity of SLN mapping of TMTP1-ICG compared to the sensitivity of SLN mapping of ICG or ICG-CP	7 days
Specificity	Specificity of SLN mapping of TMTP1-ICG compared to the sensitivity of SLN mapping of ICG or ICG-CP

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Without childbearing requirements at the time of consent.
FIGO stage IB1, IIA1 cervical cancer and is a candidate for laparoscopy intervention, with lymph node dissection being a part of the surgical plan.
Subject has provided written informed consent.

Exclusion Criteria:

Breast-feeding or pregnant.
Ongoing participation in another clinical trial with an investigational drug with 3 months
Own allergy towards ICG and/or alcohol
Diagnosis of bacterial vaginosis, fungal vaginitis, sexually transmitted diseases
Patients with cardiac dysfunction or hepatic insufficiency or renal insufficiency

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Danhui H Weng, MD	Contact	02783663351		weng.dh@gmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tongji Hospital, Tongji Medical College, HUST		Wuhan	Hubei	430030	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D002583	Uterine Cervical Neoplasms

Ancestor Terms

ID	Term
D014594	Uterine Neoplasms
D005833	Genital Neoplasms, Female
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site

Browse Leaves

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Browse Branches

Not provided