Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT00166790 |
| Other study ID # |
9461700666 |
| Secondary ID |
NSC 94-2314-B-00 |
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
September 11, 2005 |
| Last updated |
December 5, 2014 |
| Start date |
September 2005 |
| Est. completion date |
December 2014 |
Study information
| Verified date |
December 2014 |
| Source |
National Taiwan University Hospital |
| Contact |
Ruey-Jien Chen, MD, PhD |
| Phone |
886-2 -2312-3456 |
| Email |
rjchen[@]ntu.edu.tw |
| Is FDA regulated |
No |
| Health authority |
Taiwan: Department of Health |
| Study type |
Observational
|
Clinical Trial 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.
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.
