Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00166790
Status:
UNKNOWN
Last Update Posted:
2014-12-08
First Post:
2005-09-11
Brief Title:
Detection of Human Chorionic Gonadotropin by Interferometry in Gestational Trophoblastic Disease
Sponsor:
National Taiwan University Hospital
Organization:
National Taiwan University Hospital
Study Overview
Official Title:
Detection of Minimal Amount of Human Chorionic Gonadotropin by Interferometry in Gestational Trophoblastic Disease
Status:
UNKNOWN
Status Verified Date:
2014-12
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
We will try to use the novel analytical technique -Dual Polarisation Interferometry DPIto 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 patients 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 values5 mIUml However the amount of hCG produced correlates with tumor volume so that a serum hCG of 5 mIUmL corresponds to approximately 104 to 105 viable tumor cells Therefore detection of minimal amount of human chorionic gonadotropin 5 mIUml 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 proteinslipids nucleic acids lectins surfactants polymers interfacial studies surface characterisation and nanotechnology
Herein we are trying to use the novel analytical technique -Dual Polarisation Interferometry DPIto 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
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 proteinslipids nucleic acids lectins surfactants polymers interfacial studies surface characterisation and nanotechnology
Herein we are trying to use the novel analytical technique -Dual Polarisation Interferometry DPIto 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NSC 94-2314-B-002-221 | None | None | None |