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Detection of Human Chorionic Gonadotropin by Interferometry in Gestational Trophobstic Disease - Article


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Human Chorionic Gonadotropin (HCG)

A.P.L.; Chorex-10; Chorex-5; Choron-10; Gonic; Novarel; Ovidrel; Pregnyl; Profasi 




Clinical Trial: Detection of Human Chorionic Gonadotropin by Interferometry in Gestational Trophobstic Disease

This study is not yet open for patient recruitment.
Verified by National Taiwan University Hospital August 2005

Sponsors and Collaborators: National Taiwan University Hospital
National Science of Council
Information provided by: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT00166790

Purpose

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.
Condition Intervention
Trophoblastic Neoplasms
 Drug: chemotherapy agents
 Procedure: suction curettage

MedlinePlus related topics:  Cancer;   Cancer Alternative Therapies;   High Risk Pregnancy

Study Type: Observational
Study Design: Screening, Longitudinal, Defined Population, Retrospective/Prospective Study

Official Title: Detection of Minimal Amount of Human Chorionic Gonadotropin by Interferometry in Gestational Trophobstic Disease

Further Study Details: 

Expected Total Enrollment:  30

Study start: September 2005;  Expected completion: October 2006
Last follow-up: July 2006;  Data entry closure: August 2006

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.

Eligibility

Ages Eligible for Study:  20 Years   -   50 Years,  Genders Eligible for Study:  Female
Criteria

Inclusion Criteria:

  • Hydatidiform Mole
  • Choriocarcinoma
  • Gestational Trphoblastic Neoplasms

Exclusion Criteria:

  • Unwilling to participate the studyt

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00166790

Ruey-Jien Chen, MD, PhD      886-2 -2312-3456  Ext. 5158    rjchen@ha.mc.ntu.edu.tw

Taiwan
      National Taiwan University Hospital Department of Obstetrics and Gynecology, Taipei,  100,  Taiwan
Ruey-Jien Chen, MD, PhD  886-2-2312-3456  Ext. 5158    rjchen@ha.c.ntu.edu.tw 
Ruey-Jien Chen, MD, PhD,  Principal Investigator

Study chairs or principal investigators

Ruey-Jien Chen, MD, PhD,  Principal Investigator,  National Taiwan university Hospital, Department of Obstetrics and Gynecology   

More Information

Publications

Lichtenberg ES. Gestational trophoblastic tumor after medical abortion. Obstet Gynecol. 2003 May;101(5 Pt 2):1137-9.

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.

Study ID Numbers:  9461700666; NSC 94-2314-B-002-221
Last Updated:  September 13, 2005
Record first received:  September 11, 2005
ClinicalTrials.gov Identifier:  NCT00166790
Health Authority: Taiwan: Department of Health
ClinicalTrials.gov processed this record on 2005-09-20

Resources



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November 26, 2009



Page Updated: June 1, 2005
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