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Status unknownNCT01063296Updated Feb 9, 2010

Effects of Chemotherapy on Circulating Tumor Cells and Recurrences in Cervical Cancer Patients

An observational study in Cervical Cancer, sponsored by Huazhong University of Science and Technology. Status unknown at 1 site in China. Open to female participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2010-02-09.

Sponsored by Huazhong University of Science and Technology · Observational

The sponsor has not verified this record recently (last verified Jan 2010), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
400
Ages
18 Years to 70 Years
Sex
Female
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Study summary

Cervical cancer is a major health problem for Chinese women. It is estimated that nearly 100,000 new cervical cancer cases occur in China every year, which accounts for about 20 percent of global new cases. Surgery and radiotherapy are two major radical treatment methods for IB-IIB cervical cancer. Unlike the United States and some other countries, most of operable women with IB-IIB cervical cancer received radical surgery other than radiotherapy in China. Patients with recurrence risk factors (lymph node metastasis, deep stromal invasion, positive lymphatic vascular space, et al. ) also received adjuvant therapy after surgery, such as radiotherapy or chemoradiotherapy that are recommended in the NCCN guidelines. However, in China a substantial part of patients especially those admitted to tertiary hospitals received several courses of chemotherapy instead of radiotherapy if they had recurrence risk factors .

In our previous study, we found that patients with intermediate risk factors (deep stromal invasion, positive lymphatic vascular space, bulky tumor>4cm) had better disease-free survival and recurrence-free survival when they received chemotherapy compared with radiotherapy. The objective in this study is to investigate whether the advantage of postoperative chemotherapy is a result of circulating tumor cells (CTC) in some of the patients with intermediate risk factors.

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Conditions studied

  • Cervical Cancer

Keywords

  • cervical cancer
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In context

Uterine Cervical Neoplasms

1,881 studies on the registry are indexed under Uterine Cervical Neoplasms; 567 are open to participants now.

This study's planned enrollment of 400 is above the median of 220 across 419 observational studies indexed under Uterine Cervical Neoplasms.

Browse Uterine Cervical Neoplasms studies →

Lead sponsor

Huazhong University of Science and Technology is the lead sponsor of 241 studies on the registry; 60 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients with histologically confirmed Ib\~IIa cervical carcinoma without previous treatments

Inclusion criteria

  • Patients with histologically confirmed Ib\~IIa (FIGO)cervical carcinoma without previous treatments
  • Age between 18-70
  • With the presence of these three pathological risk factors after radical surgery:(1) positive lymphatic vascular space,(2)outer one-third invasion of the cervical stroma, (3) bulky tumor≥4cm
  • At least 3 months of disease-free survival

Exclusion criteria

Exclusion Criteria:

  • The presence of other uncontrolled life-threatening disease (Suffering from myocardial infarction or stroke, or unstable angina, decompensated heart failure, or a history of deep vein thrombosis)
  • Receiving other anti-cancer therapy, such as traditional Chinese drug
  • Don't be able to finish the whole treatment(chemotherapy or radiotherapy)
  • liver dysfunction (ALT、AST>2.5×ULN)
  • renal dysfunction (Creatinine>1.5×ULN)
  • WBC\<4,000/mm3 or PLT\<100,000/mm3
  • Received preoperative radiotherapy
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
400 participants (estimated)
Biospecimen retention
Samples with dna
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What researchers measure

Primary outcomes

  1. The occurrence rate of CTCs, distant metastasis-free survival, disease-free survival, metastatic sites

    Time frame: 3 years

Secondary outcomes

  1. Overall survival

    Time frame: 3 years

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Study locations

1 site
  • Tongji Hospital of HUST
    Wuhan, Hubei, China
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 9, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01063296
Lead sponsor
Huazhong University of Science and Technology
First posted
Feb 5, 2010
Start date
Mar 2010
Primary completion
Jan 2014 (estimated)
Completion
Jan 2014 (estimated)
Last update
Feb 9, 2010

Study contacts

Ma Ding, M.D.
Contact
dma@tjh.tjmu.edu.cn
86-27-8362681
Ma Ding, M.D.
study director · Tongji Hospital of HUST

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2010. You cannot join it, but the record below documents what was studied.

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