NCT00166790

Brief Summary

We will try to use the novel analytical technique -Dual Polarisation Interferometry (DPI),to achieve detection the minimal amount of the human chorionic gonadotropin for early detection and strict monitor of the GTD.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2005

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

September 11, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 14, 2005

Completed
9.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

December 8, 2014

Status Verified

December 1, 2014

Enrollment Period

9.3 years

First QC Date

September 11, 2005

Last Update Submit

December 5, 2014

Conditions

Trophoblastic Neoplasms

Keywords

Human Chorionic GonadotropinDual Polarization Interferometry,Gestational Trophoblastic Neoplasms

Outcome Measures

Primary Outcomes (1)

  • HCG LEVEL

    REMISSION

Interventions

chemotherapy agentsDRUG
suction curettagePROCEDURE

Eligibility Criteria

Age20 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

GTD

You may qualify if:

  • Hydatidiform Mole
  • Choriocarcinoma
  • Gestational Trophoblastic Neoplasms

You may not qualify if:

  • Unwilling to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital Department of Obstetrics and Gynecology

Taipei, Taipei, 100, Taiwan

RECRUITING

Related Publications (2)

  • Lichtenberg ES. Gestational trophoblastic tumor after medical abortion. Obstet Gynecol. 2003 May;101(5 Pt 2):1137-9. doi: 10.1016/s0029-7844(03)00062-0.

    PMID: 12738129BACKGROUND

  • Behtash N, Ghaemmaghami F, Honar H, Riazi K, Nori A, Modares M, Mousavi A. Is normal beta-hCG regression curve helpful in the diagnosis of persistent trophoblastic disease? Int J Gynecol Cancer. 2004 Sep-Oct;14(5):980-3. doi: 10.1111/j.1048-891X.2004.14538.x.

    PMID: 15361212BACKGROUND

MeSH Terms

Conditions

Trophoblastic NeoplasmsGestational Trophoblastic Disease

Interventions

Vacuum Curettage

Condition Hierarchy (Ancestors)

Neoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsPregnancy Complications, NeoplasticPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

Dilatation and CurettageCurettageSurgical Procedures, OperativeGynecologic Surgical ProceduresUrogenital Surgical Procedures

Study Officials

  • Ruey-Jien Chen, MD, PhD

    National Taiwan university Hospital, Department of Obstetrics and Gynecology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ruey-Jien Chen, MD, PhD

CONTACT

886-2 -2312-3456rjchen@ntu.edu.tw

Study Design

Study Type
observational
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 11, 2005

First Posted

September 14, 2005

Study Start

September 1, 2005

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

December 8, 2014

Record last verified: 2014-12

Locations

TW(1)