Detection of Human Chorionic Gonadotropin by Interferometry in Gestational Trophoblastic Disease

NCT ID: NCT00166790

Last Updated: 2014-12-08

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2005-09-30
• Study Completion Date: 2014-12-31

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.

Conditions

Trophoblastic Neoplasms

Keywords

Human Chorionic Gonadotropin; Dual Polarization Interferometry,; Gestational Trophoblastic Neoplasms

Interventions

chemotherapy agents

Intervention Type: DRUG

suction curettage

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Hydatidiform Mole
• Choriocarcinoma
• Gestational Trophoblastic Neoplasms

Exclusion Criteria

• Unwilling to participate in the study

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Science and Technology Council, Taiwan

OTHER_GOV

Sponsor Role: collaborator

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ruey-Jien Chen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

National Taiwan university Hospital, Department of Obstetrics and Gynecology

Locations

National Taiwan University Hospital Department of Obstetrics and Gynecology

Taipei, Taipei, Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Ruey-Jien Chen, MD, PhD

Role: CONTACT

Phone: 886-2 -2312-3456

Email: rjchen@ntu.edu.tw

Facility Contacts

Ruey-Jien Chen, MD, PhD

Role: primary

References

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.

Reference Type: BACKGROUND

PMID: 12738129 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15361212 (View on PubMed)

Other Identifiers

NSC 94-2314-B-002-221

Identifier Type: -

Identifier Source: secondary_id

9461700666

Identifier Type: -

Identifier Source: org_study_id