Detection of Human Chorionic Gonadotropin by Interferometry in Gestational Trophoblastic Disease
Primary Purpose
Trophoblastic Neoplasms
Status
Unknown status
Phase
Locations
Taiwan
Study Type
Observational
Intervention
chemotherapy agents
suction curettage
Sponsored by
About this trial
This is an observational trial for Trophoblastic Neoplasms focused on measuring Human Chorionic Gonadotropin, Dual Polarization Interferometry,, Gestational Trophoblastic Neoplasms
Eligibility Criteria
Inclusion Criteria: Hydatidiform Mole Choriocarcinoma Gestational Trophoblastic Neoplasms Exclusion Criteria: Unwilling to participate in the study
Sites / Locations
- National Taiwan University Hospital Department of Obstetrics and GynecologyRecruiting
Outcomes
Primary Outcome Measures
HCG LEVEL
Secondary Outcome Measures
Full Information
NCT ID
NCT00166790
First Posted
September 11, 2005
Last Updated
December 5, 2014
Sponsor
National Taiwan University Hospital
Collaborators
National Science Council, Taiwan
1. Study Identification
Unique Protocol Identification Number
NCT00166790
Brief Title
Detection of Human Chorionic Gonadotropin by Interferometry in Gestational Trophoblastic Disease
Official Title
Detection of Minimal Amount of Human Chorionic Gonadotropin by Interferometry in Gestational Trophoblastic Disease
Study Type
Observational
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Unknown status
Study Start Date
September 2005 (undefined)
Primary Completion Date
December 2014 (Anticipated)
Study Completion Date
December 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital
Collaborators
National Science Council, Taiwan
4. Oversight
5. Study Description
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.
Detailed Description
1 Gestational trophoblastic disease (GTD) consists of a spectrum of disorders that are characterized by an abnormal proliferation of trophoblastic tissue. They include hydatidiform mole, invasive mole, choriocarcinoma and placental site trophoblastic tumor (PSTT). The incidence of molar pregnancies in Asian countries is 7 to 10 times greater than the reported incidence in Europe or North America. Although previously a lethal disease, GTD is considered today the most curable gynecologic cancer. This progress can be attributed to an available tumor markerhuman chorionic gonadotropin (hCG), chemosensitivity, and the incorporation of aggressive multimodality therapy. However, a delay in the diagnosis may increase the patient's risk of developing malignant GTN and adversely affect response to treatment, and therefore the prompt identification of GTN is important. Approximately 20% of patients will develop malignant sequelae requiring administration of chemotherapy after evacuation of hydatidiform moles. The overall cure rate for patients with nonmetastatic disease and low-risk metastatic disease is nearly 100% .When chemotherapy is given for an additional 1-2 cycles after the first normal hCG value, recurrence rates are less than 5%. In contrast, in high risk metastatic disease, chemotherapy is continued until hCG values have normalized, followed by at least two or three courses of maintenance chemotherapy in the hopes of eradicating all viable tumors. Despite the use of sensitive hCG assays and maintenance chemotherapy, up to 13% of patients with high-risk disease will develop recurrence after achieving an initial remission. Conventionally, serial quantitative serum hCG determinations should be performed using commercially available assays capable of detecting β-hCG to baseline values(<5 mIU/ml). However, the amount of hCG produced correlates with tumor volume so that a serum hCG of 5 mIU/mL corresponds to approximately 104 to 105 viable tumor cells. Therefore, detection of minimal amount of human chorionic gonadotropin (<5 mIU/ml) is crucial, it could help to early detect the GTD and strictly monitor the residual activity of the tumor after chemotherapy.
Dual Polarisation Interferometry (DPI) is an analytical technique used to understand the real-time structure and behaviour of a wide range of molecular systems and interactions through quantitative measurement including molecular size, density and mass. DPI has been successful across a range of applications, including proteins,lipids, nucleic acids, lectins, surfactants, polymers, interfacial studies, surface characterisation and nanotechnology.
Herein, we are trying 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. Under this circumstance, maintenance chemotherapy is continued until hCG values is totally undetectable, in the hopes of eradicating all viable tumors. Besides this method could be more precise in sensitivity and specificity to avoid the false positive result which could led to unnecessary chemotherapy or surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trophoblastic Neoplasms
Keywords
Human Chorionic Gonadotropin, Dual Polarization Interferometry,, Gestational Trophoblastic Neoplasms
7. Study Design
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
chemotherapy agents
Intervention Type
Procedure
Intervention Name(s)
suction curettage
Primary Outcome Measure Information:
Title
HCG LEVEL
Time Frame
REMISSION
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Hydatidiform Mole
Choriocarcinoma
Gestational Trophoblastic Neoplasms
Exclusion Criteria:
Unwilling to participate in the study
Study Population Description
GTD
Sampling Method
Probability Sample
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ruey-Jien Chen, MD, PhD
Phone
886-2 -2312-3456
Ext
5158
Email
rjchen@ntu.edu.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ruey-Jien Chen, MD, PhD
Organizational Affiliation
National Taiwan university Hospital, Department of Obstetrics and Gynecology
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital Department of Obstetrics and Gynecology
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ruey-Jien Chen, MD, PhD
Phone
886-2-2312-3456
Ext
5158
Email
rjchen@ntu.edu.tw
First Name & Middle Initial & Last Name & Degree
Ruey-Jien Chen, MD, PhD
12. IPD Sharing Statement
Citations:
PubMed Identifier
12738129
Citation
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.
Results Reference
background
PubMed Identifier
15361212
Citation
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.
Results Reference
background
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Detection of Human Chorionic Gonadotropin by Interferometry in Gestational Trophoblastic Disease
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