A Phase 1 interventional study of TMTP1 and ICG in Cervical Intraepithelial Neoplasia, sponsored by Huazhong University of Science and Technology. Status unknown at 1 site in China. Open to female participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2021-06-30.
Sponsored by Huazhong University of Science and Technology · Phase 1, Interventional, and Diagnostic
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Among 55 studies in Uterine Cervical Dysplasia with a site in China — 10 open to participants now, 14 under way, 1 of them phase 3. Uterine Cervical Dysplasia · China.
Among the 55 studies in Uterine Cervical Dysplasia with a site in China, this one is the 32nd largest by planned enrollment of the 34 interventional ones that give a count, is one of 5 that started in 2017, is one of 5 in phase 1, and was the 22nd registered.
409 studies on the registry are indexed under Uterine Cervical Dysplasia; 76 are open to participants now.
Browse Uterine Cervical Dysplasia studies →10 of the 55 studies in Uterine Cervical Dysplasia with a site in China are open now. Recruiting first, the newest first:
Fujian Maternity and Child Health Hospital · Sites in China
Ages up to 45 · Women only
First Hospital of China Medical University · Sites in China
Ages 18–65 · Women only
Shanghai Zerun Biotechnology Co.,Ltd · Sites in China
Ages 12–34 · Women only · Healthy volunteers
Tongji Hospital · Sites in China
Ages 18–50 · Women only
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Sites in China
Ages 18 days+ · Women only
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 43 Uterine Cervical Dysplasia studies recruiting now, 19 (44%) set no upper age limit and 21 (49%) stop at 75 or younger; 3 take children under 18; 11 take healthy volunteers.
This study: 18 Years to 60 Years · female · no healthy volunteers.
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55 studies; the count open now beside each. This study's row is marked.
First in 2005; this study’s year is marked. 5 started in 2017.
This study's planned enrollment of 40 is below the median of 167 across 285 interventional studies indexed under Uterine Cervical Dysplasia.
Median enrollment 330 across the 34 interventional studies, 1,200 across the 21 observational. Of the 18 that completed or were terminated, 5 (28%) have results posted.
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11 of 55 have an industry lead sponsor. The 10 most frequent:
Huazhong University of Science and Technology is the lead sponsor of 247 studies on the registry; 62 are open to participants now.
Huazhong University of Science and Technology has 5 studies filed under Uterine Cervical Dysplasia — fewer than ten, so there is no comparison to draw.
2 of the studies in Uterine Cervical Dysplasia with a site in China that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07833852Shanghai Zerun Biotechnology Co.,LtdLong-Term Immune Persistence After Bivalent HPV Vaccination in Females From Study 311-HPV-1005 | 2026-12 |
| NCT06243666Xiamen UniversityLong-term Effectiveness and Immuno-persistence Study of a Recombinant HPV 16/18 Bivalent Vaccine in Preadolescent Girls | 2026-12-31 |
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Among the 55 studies in Uterine Cervical Dysplasia with a site in China, from their registry updates:
This tab as a report to print or save as PDF → With an account.
Investigators aimed to determine the validity of the novel tumor targeted fluorescent TMTP1-ICG to increased accuracy of colposcopy-directed biopsy.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The TMTP1-ICG (WuXi AppTec, Shanghai, China) powder was diluted in 20 ml of aqueous sterile water to a concentration of 1.0 mg/mL. Then TMTP1-ICG spray was applied thoroughly to the ectocervix for 30 minutes. After cleaned by NS, fluorescent detected sites will be removed.
Drug: TMTP1
The ICG (WuXi AppTec, Shanghai, China) powder was diluted in 20 ml of aqueous sterile water to a concentration of 1.0 mg/mL. ICG spray was applied thoroughly to the ectocervix for 30 minutes. After cleaned by NS, fluorescent detected sites will be removed.
Drug: ICG
Fluorescent sites will be removed
Fluorescent sites will be removed
Sensitivity
Sensitivity of fluorescent detection of TMTP1-ICG compared to the sensitivity of ICG
Time frame: 1 day
Specificity
Specificity of fluorescent detection of TMTP1-ICG compared to the sensitivity of ICG
Time frame: 7 days
Incidence of adverse events
Time frame: 7 days
Ran from Nov 2017 to primary completion in Aug 2020, 33 months.
Of 14 phase 1 interventional studies under Uterine Cervical Dysplasia, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 67. This study's 33 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.
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Huazhong University of Science and Technology →