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Endometrial CancerNCT00166985

The Role of Functional MRI and Doppler Sonography in Assessing Blood Vessel Formation Within the Tumors of Endometrial Cancer Patients

An observational study of Endometrial Cancer, run by National Taiwan University Hospital at 1 site in Taiwan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Adenocarcinoma of the endometrium is the fourth most frequent cancer in women. Surgery is the treatment of choice in patients with noninvasive or locally advanced disease. The surgical technique consists of an exploratory laparotomy, with total hysterectomy, bilateral oophorectomy, peritoneal washing, and, in selected… Read more about this study

Who is it for?
Ages 18 to 80 years, women only
Conditions the study is for
Endometrial Cancer
How many people
200 participants
Where
1 siteTaiwan
Study dates
Sep 2004to Dec 2008
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 18 to 80 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Endometrial cancer patients with histopathologic proof who are arranged to receive staging surgery.
  • All of the patients who will be enrolled into this study need to sign the consent form and the study protocol will be under the approval of the Institutional Review Board of the patient's hospital.

Who cannot join

  • Tumors of histologic types other than adenocarcinoma and adenoacanthoma will be excluded.

Trial locations and contacts

1 site in 1 country.

Taiwan1 site, 1 recruiting
  • National Taiwan University Hospital

    Taipei

    Chi-An Chen, MD, 886-2-2312-3456 ext. 5157, cachen@ha.mc.ntu.edu.tw

    Recruiting

Other trials in Taiwan

About this study

Official title: The Role of Functional MRI and Doppler Sonography in Assessing Intratumoral Angiogenesis of Endometrial Cancer Patients

Adenocarcinoma of the endometrium is the fourth most frequent cancer in women. Surgery is the treatment of choice in patients with noninvasive or locally advanced disease. The surgical technique consists of an exploratory laparotomy, with total hysterectomy, bilateral oophorectomy, peritoneal washing, and, in selected high-risk patients, omental and peritoneal biopsies and lymphadenectomy. Therefore, preoperative clinical and instrumental staging of the local spread of disease, as well as local and distant lymph node involvement, represent a critical step in tailoring the extent and the radicalness of surgery.

The role of angiogenesis in cancer growth and metastasis has been gaining much attention for decades. Recent clinical evidence supports this notion. The gradual increase in angiogenesis intensity with tumor progression in malignant melanoma has been reported. Abulafia et al. reported that increasing angiogenicity could be noted from simple hyperplasia, complex hyperplasia, atypical hyperplasia, and Stage IA endometrial carcinoma to invasive endometrial carcinoma. The investigators' research team has shown that incremental angiogenesis could be demonstrated in the tumorigenesis and the possibility of lymph node metastasis in endometrial malignancy. Besides, other growth factors such as vascular endothelial growth factor (VEGF), transforming growth factor- (TGF-), IL-6 and IL-8 have also been reported to correlate with the angiogenesis and the metastasis of endometrial cancer. It seems that tumor angiogenesis of endometrial cancer could be utilized as an important parameter to assess the disease severity of the endometrial cancer.

So, the investigators would like to propose this proposal to focus on the tumor angiogenesis in endometrial cancer patients. There are several purposes in this study. First, the investigators will evaluate and compare tumor angiogenesis surveyed from functional MRI and power Doppler sonography in endometrial cancer patients who receive surgery. Second, the investigators will evaluate whether tumor angiogenesis could be a marker to predict the disease severity of endometrial cancer. Third, the role of functional magnetic resonance imaging (MRI) in endometrial cancer will be elucidated.

Read the detailed description

Adenocarcinoma of the endometrium is the fourth most frequent cancer in women. Surgery is the treatment of choice in patients with noninvasive or locally advanced disease. The surgical technique consists of an exploratory laparotomy, with total hysterectomy, bilateral oophorectomy, peritoneal washing, and, in selected high-risk patients, omental and peritoneal biopsies and lymphadenectomy. Therefore, preoperative clinical and instrumental staging of the local spread of disease, as well as local and distant lymph node involvement, represent a critical step in tailoring the extent and the radicalness of surgery.

The role of angiogenesis in cancer growth and metastasis has been gaining much attention for decades. Recent clinical evidence supports this notion. The gradual increase in angiogenesis intensity with tumor progression in malignant melanoma has been reported. Abulafia et al. observed that increasing angiogenicity from simple hyperplasia, complex hyperplasia, atypical hyperplasia, and Stage IA endometrial carcinoma to invasive endometrial carcinoma has been found by histopathologic examination. Several articles have reported that transvaginal color and pulse Doppler ultrasound may be helpful blood in the evaluation of various gynecologic tumors. Besides, our previous studies have also shown that incremental angiogenesis could be demonstrated in the tumorigenesis and the possibility of lymph node metastasis in endometrial malignancy. Other growth factors such as vascular endothelial growth factor (VEGF), TGF-, IL-6, and IL-8 have also been reported to correlate with the angiogenesis and the metastasis of endometrial cancer. It seems that tumor angiogenesis of endometrial cancer could be utilized as an important parameter to assess the disease severity of the endometrial cancer.

Determining microvessel density is regarded as a standard procedure to quantitate tumor angiogenesis. However, microvessel density always has been assessed retrospectively and in vitro. Preoperative prediction of the microvessel density would be of value clinically for evaluating severity and progression of disease.

So, we would like to propose this proposal to focus on the tumor angiogenesis in endometrial cancer patients. Endometrial cancer patients who will receive staging surgery will be enrolled in this study. Functional MRI, and transvaginal sonography will be undergone before the surgery in each patient. The angiogenesis-related growth factors will be evaluated later from the surgical specimens. The clinical pathologic items, various angiogenic parameters obtained from the MRI and sonography, and angiogenesis-related factors will be compared and correlated together. There are several purposes in this study. First, we will evaluate and compare tumor angiogenesis surveyed from functional MRI and power Doppler sonography in endometrial cancer patients who receive surgery. Second, we will evaluate whether tumor angiogenesis could be a marker to predict the disease severity of endometrial cancer. Third, we will elucidate the role of functional MRI in endometrial cancer.

Endometrial cancer patients with histopathologic proof who are arranged to receive staging surgery are eligible. All patients will undergo surgery, including total abdominal hysterectomy, bilateral salpingo-oophorectomy, and pelvic and/or para-aortic lymph node dissection or sampling. Surgical specimens will be evaluated for tumor size, histologic grading, depth of myometrial invasion, and presence of lymphovascular emboli and lymph node metastasis. Stage will be determined using the International Federation of Gynecology and Obstetrics classification. Tumors of histologic types other than adenocarcinoma and adenoacanthoma will be excluded. The carcinomas were classified using a three-grade system: grade 1 carcinomas showed glandular formation in more than 95% of the tumor, grade 2 carcinomas showed a solid growth pattern in 5-50%, and grade 3 carcinomas showed a solid pattern in more than 50%. All of the patients who will be enrolled into this study need to sign the consent form and the study protocol will be under the approval of the Institutional Review Board of the patient's hospital.

Keywords
endometrial cancer, MRI, Doppler sonography, angiogenesis
Medical subject headings
Endometrial Neoplasms

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Sep 2005 (estimated)
  2. Study startSep 2004
  3. Study completionDec 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Defined population
Time perspective
Other
Enrolment
200 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00166985
Sponsor's protocol ID
9361701182
Status last verified
Aug 2004
First submitted
12 Sep 2005
Last updated
27 Dec 2006
Results posted
No

Questions about this trial

What is this clinical trial studying?

An observational study of Endometrial Cancer, 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 2 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 27 Dec 2006. 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 Chi-An Chen, MD (886-2-2312-3456 ext. 5157, cachen@ha.mc.ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?
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 27 Dec 2006.

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