Cervical CancerNCT03549195
TMTP1 Targeting Micro-metastasis LN in Laparoscopic SLN Detection in Cervical Cancer
A study testing ICG, ICG-CP and ICG-TMTP1 in people with Cervical Cancer and Sentinel Lymph Node, run by Huazhong University of Science and Technology at 1 site in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 30 to 60 years, women only
- Conditions the study is for
- Cervical Cancer, Sentinel Lymph Node
- What is being tested?
- ICG, ICG-CP and ICG-TMTP1
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2018to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Tongji Hospital, Tongji Medical College, HUST
Wuhan, Hubei, 430030
Danhui Weng, MD, 02783663351 ext. 02783663351, weng.dh@gmail.com
About this study
Official title: Novel Tumor Targeted Fluorescent Peptide TMTP1-ICG Mapping in Laparoscopic Sentinel Micro-metastasis Lymph Node Detection in Cervical Cancer Patients
Investigators aimed to determine the validity of the investigator's novel tumor targeted fluorescent peptide TMTP1-ICG to increased accuracy of laparoscopic SLN mapping
- Conditions
- Cervical Cancer, Sentinel Lymph Node
- Being tested
- ICG, ICG-CP, ICG-TMTP1
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICGProcedure or surgery
The ICG powder was diluted and injected into the cervix, divided into 3 and 9 o'clock position, 4 hours before surgery.
ICG-CPProcedure or surgery
The ICG-CP powder was diluted and injected into the cervix, divided into 3 and 9 o'clock position, 4 hours before surgery.
ICG-TMTP1Procedure or surgery
The ICG-TMTP1 powder was diluted and injected into the cervix, divided into 3 and 9 o'clock position, 4 hours before surgery.
| Study group | Role | What they receive |
|---|---|---|
| ICG | Active comparator | Not described Receives: Procedure: ICG |
| ICG-CP | Active comparator | CP, control peptide Receives: Procedure: ICG-CP |
| ICG-TMTP1 | Experimental | also named as TMTP1-ICG Receives: Procedure: ICG-TMTP1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection rate of micro-metastasis sentinel lymph node
Detection of micro-metastasis sentinel lymph node per patient
Measured: 7 days
Secondary outcomes (3)
Sensitivity
Sensitivity of SLN mapping of TMTP1-ICG compared to the sensitivity of SLN mapping of ICG or ICG-CP
Measured: 7 days
Specificity
Specificity of SLN mapping of TMTP1-ICG compared to the sensitivity of SLN mapping of ICG or ICG-CP
Measured: 7 days
Incidence of adverse events
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2018
- Study start1 Jun 2018 (estimated)
- Primary completion1 Jun 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by Huazhong University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ding Ma, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03549195
- Sponsor's protocol ID
- TMTP1-ICG-03
- Status last verified
- May 2018
- First submitted
- 25 May 2018
- Last updated
- 7 Jun 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Tumor Targeted Fluorescent Peptide TMTP1-ICG Mapping in Laparoscopic Sentinel Micro-metastasis Lymph Node Detection in Cervical Cancer Patients
- ClinicalTrials.gov ID
- NCT03549195
- Acronym / sponsor ID
- TMTP1-ICG-03
- Conditions
- Cervical Cancer, Sentinel Lymph Node
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 1 Jun 2018 (estimated)
- Primary completion
- 1 Jun 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 7 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Investigators aimed to determine the validity of the investigator's novel tumor targeted fluorescent peptide TMTP1-ICG to increased accuracy of laparoscopic SLN mapping
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ICG | Active comparator | Procedure: ICG |
| ICG-CP | Active comparator | Procedure: ICG-CPCP, control peptide |
| ICG-TMTP1 | Experimental | Procedure: ICG-TMTP1also named as TMTP1-ICG |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ICGThe ICG powder was diluted and injected into the cervix, divided into 3 and 9 o'clock position, 4 hours before surgery. | Procedure or surgery | ICG |
| ICG-CPThe ICG-CP powder was diluted and injected into the cervix, divided into 3 and 9 o'clock position, 4 hours before surgery. | Procedure or surgery | ICG-CP |
| ICG-TMTP1The ICG-TMTP1 powder was diluted and injected into the cervix, divided into 3 and 9 o'clock position, 4 hours before surgery. | Procedure or surgery | ICG-TMTP1 |
Primary outcome
Detection rate of micro-metastasis sentinel lymph node
Time frame: 7 days
Detection of micro-metastasis sentinel lymph node per patient
3 secondary outcomes
Sensitivity
Time frame: 7 days
Specificity
Time frame: 7 days
Incidence of adverse events
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ICG, ICG-CP and ICG-TMTP1 in people with Cervical Cancer and Sentinel Lymph Node, run by Huazhong University of Science and Technology at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Danhui H Weng, MD (02783663351, weng.dh@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection rate of micro-metastasis sentinel lymph node (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2018.