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Trial Title:
DKI Combined With APT for Post-treatment Assessment of Ovarian Malignancies and Correlation With XRCC2 Gene
NCT ID:
NCT05642871
Condition:
Malignant Tumor of the Ovary
XRCC2 Gene Mutation
Conditions: Official terms:
Ovarian Neoplasms
Study type:
Observational
Overall status:
Not yet recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Radiation
Intervention name:
DKI and APT
Description:
DKI and APT in patients with ovarian malignancy before and after treatment
Arm group label:
Magnetic Resonance Multifunctional Imaging
Summary:
Ovarian cancer is one of the common causes of cancer death in women worldwide. Despite
the continuous development of diagnostic and treatment techniques, the survival rate of
ovarian cancer patients has not improved significantly, and the important reason for the
high mortality rate and poor prognosis is the lack of effective means to assess the
effectiveness of treatment. The methods to monitor the effectiveness of ovarian cancer
treatment and dynamic risk stratification by conventional imaging or single tumour marker
levels are rather limited. In recent years, DKI and APT imaging have made some
achievements in evaluating the post-treatment outcome of tumours, and the quantitative
parameters of DKI combined with APT as a non-invasive biological marker are expected to
be an effective way to address the limitations of assessing the treatment outcome by
non-invasively detecting the changes in the signal of water protons and the diffusion
information of non-normally distributed water molecules in the tumour tissue to observe
the changes of protein and microstructure in the tumour cells. This project aims to
collect patients who have come to our hospital for treatment. This project aims to
collect patients with ovarian malignancies who come to our hospital and perform DKI, APT
sequence and XRCC2 gene examination before and after treatment, and to statistically
analyse the obtained parameters to assess the value of DKI combined with APT in
monitoring the treatment effect of ovarian malignancies and the correlation with XRCC2
gene. This will help to promote individualised and precise treatment of ovarian cancer
and improve prognosis.
Criteria for eligibility:
Study pop:
Patients with first diagnosis of ovarian malignancy; enrolled patients receive paclitaxel
+ cisplatin combination chemotherapy in 3-week cycles, with efficacy assessed every 3
cycles
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
No previous history of ovarian tumours or ovarian surgery; no concurrent other tumours,
no history of oncology or treatment such as radiotherapy or chemotherapy; confirmed by
pathological histology; receiving chemotherapy with a combination of platinum and purple
shirt for at least 3 cycles; no contraindications to MRI
Exclusion Criteria:
Recurrent ovarian malignancy; too old, poor physical infrastructure; severe medical
comorbidity; incomplete patient data collection; lost to follow-up
Gender:
Female
Minimum age:
40 Years
Maximum age:
70 Years
Healthy volunteers:
No
Start date:
January 31, 2023
Completion date:
August 31, 2025
Lead sponsor:
Agency:
Qianqian Qu
Agency class:
Other
Source:
Qianfoshan Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05642871