Detection of Human Chorionic Gonadotropin by Interferometry in Gestational Trophoblastic Disease

Detection of Minimal Amount of Human Chorionic Gonadotropin by Interferometry in Gestational Trophoblastic Disease

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.

Study Overview

• Status: Unknown
• Conditions: Trophoblastic Neoplasms
• Intervention / Treatment: Drug: chemotherapy agents; Procedure: suction curettage

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.

• Study Type: Observational
• Enrollment (Anticipated): 30

Contacts and Locations

• Study Contact: Name: Ruey-Jien Chen, MD, PhD; Phone Number: 5158 886-2 -2312-3456; Email: rjchen@ntu.edu.tw

Study Locations

• Taiwan
  • Taipei, Taiwan, 100
    • Recruiting
    • National Taiwan University Hospital Department of Obstetrics and Gynecology
    • Principal Investigator: Ruey-Jien Chen, MD, PhD
    • Contact: Ruey-Jien Chen, MD, PhD; Phone Number: 5158 886-2-2312-3456; Email: rjchen@ntu.edu.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

GTD

Description

Inclusion Criteria:

• Hydatidiform Mole
• Choriocarcinoma
• Gestational Trophoblastic Neoplasms

Exclusion Criteria:

• Unwilling to participate in the study

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
HCG LEVEL	REMISSION

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Collaborators: National Science Council, Taiwan
• Investigators: Principal Investigator: Ruey-Jien Chen, MD, PhD, National Taiwan university Hospital, Department of Obstetrics and Gynecology

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2005
• Primary Completion (Anticipated): December 1, 2014
• Study Completion (Anticipated): December 1, 2014

Study Registration Dates

• First Submitted: September 11, 2005
• First Submitted That Met QC Criteria: September 11, 2005
• First Posted (Estimate): September 14, 2005

Study Record Updates

• Last Update Posted (Estimate): December 8, 2014
• Last Update Submitted That Met QC Criteria: December 5, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: Human Chorionic Gonadotropin; Dual Polarization Interferometry,; Gestational Trophoblastic Neoplasms
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Germ Cell and Embryonal; Pregnancy Complications; Pregnancy Complications, Neoplastic; Trophoblastic Neoplasms; Gestational Trophoblastic Disease
• Other Study ID Numbers: 9461700666; NSC 94-2314-B-002-221