Trophoblastic NeoplasmsNCT00166790
Detection of Human Chorionic Gonadotropin by Interferometry in Gestational Trophoblastic Disease
An observational study of Trophoblastic Neoplasms, run by National Taiwan University Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 to 50 years, women only
- Conditions the study is for
- Trophoblastic Neoplasms
- What is being tested?
- chemotherapy agents and suction curettage
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- Sep 2005to Dec 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- Women only
- No healthy volunteers
- Adult
Study population: GTD
Who may be able to join
- Hydatidiform Mole
- Choriocarcinoma
- Gestational Trophoblastic Neoplasms
Who cannot join
- Unwilling to participate in the study
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital Department of Obstetrics and Gynecology
Taipei, Taipei, 100
Ruey-Jien Chen, MD, PhD, 886-2-2312-3456 ext. 5158, rjchen@ntu.edu.tw
Ruey-Jien Chen, MD, PhD
About this study
Official title: 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.
Read the 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
- Being tested
- chemotherapy agents, suction curettage
- Keywords
- Human Chorionic Gonadotropin, Dual Polarization Interferometry,, Gestational Trophoblastic Neoplasms
- Medical subject headings
- Trophoblastic Neoplasms, Gestational Trophoblastic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chemotherapy agentsDrug
suction curettageProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
HCG LEVEL
Measured: REMISSION
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2005 (estimated)
- Study startSep 2005
- Primary completionDec 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Trophoblastic NeoplasmsStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Responsible party
- Sponsor
- Investigators
- Ruey-Jien Chen, MD, PhD, Principal investigator, National Taiwan university Hospital, Department of Obstetrics and Gynecology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00166790
- Sponsor's protocol ID
- 9461700666
- Other IDs
- NSC 94-2314-B-002-221
- Status last verified
- Dec 2014
- First submitted
- 11 Sep 2005
- Last updated
- 8 Dec 2014
- Results posted
- No
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.
PubMed 12738129Behtash 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.
PubMed 15361212
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Minimal Amount of Human Chorionic Gonadotropin by Interferometry in Gestational Trophoblastic Disease
- ClinicalTrials.gov ID
- NCT00166790
- Acronym / sponsor ID
- 9461700666
- Conditions
- Trophoblastic Neoplasms
- Keywords
- Human Chorionic Gonadotropin, Dual Polarization Interferometry,, Gestational Trophoblastic Neoplasms
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Study start
- Sep 2005
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 14 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- GTD
Key inclusion criteria (3 listed)
- Hydatidiform Mole
- Choriocarcinoma
- Gestational Trophoblastic Neoplasms
Key exclusion criteria (1 listed)
- Unwilling to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| chemotherapy agents | Drug | – |
| suction curettage | Procedure or surgery | – |
Primary outcome
HCG LEVEL
Time frame: REMISSION
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2014.
- Background: PubMed 12738129Lichtenberg 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.
- Background: PubMed 15361212Behtash 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ruey-Jien Chen, MD, PhD principal investigator
National Taiwan university Hospital, Department of Obstetrics and Gynecology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Trophoblastic Neoplasms, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ruey-Jien Chen, MD, PhD (886-2 -2312-3456 ext. 5158, rjchen@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HCG LEVEL (time frame: REMISSION). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00166790, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2014.