Malignant Tumor of the OvaryNCT05642871
DKI Combined With APT for Post-treatment Assessment of Ovarian Malignancies and Correlation With XRCC2 Gene
An observational study of Malignant Tumor of the Ovary and XRCC2 Gene Mutation, run by Qianqian Qu.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 70 years, women only
- Conditions the study is for
- Malignant Tumor of the Ovary, XRCC2 Gene Mutation
- What is being tested?
- DKI and APT
- Type of treatment
- Surgery or procedure
- How many people
- 2 participants
- Where
- No sites listed yet
- Study dates
- 31 Jan 2023to 31 Aug 2025
- 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 40 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with first diagnosis of ovarian malignancy; enrolled patients receive paclitaxel + cisplatin combination chemotherapy in 3-week cycles, with efficacy assessed every 3 cycles
Who may be able to join
- 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
Who cannot join
- Recurrent ovarian malignancy; too old, poor physical infrastructure; severe medical comorbidity; incomplete patient data collection; lost to follow-up
About this study
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.
- Conditions
- Malignant Tumor of the Ovary, XRCC2 Gene Mutation
- Being tested
- DKI and APT
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DKI and APTRadiation
DKI and APT in patients with ovarian malignancy before and after treatment
| Study group | Role | What they receive |
|---|---|---|
| Magnetic Resonance Multifunctional Imaging | Not described Receives: Radiation: DKI and APT |
What is being measured
The primary outcome is the main question the study is designed to answer.
DKI diffusion indicators and APT signal values
MK MD SI
Measured: 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2022
- Study start31 Jan 2023 (estimated)
- Primary completion1 Jun 2024 (estimated)
- Study completion31 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Tumor of the OvaryStudies of the same condition, open and under way.
- 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
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 2 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qianqian Qu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Qianqian Qu, Qianfoshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05642871
- Sponsor's protocol ID
- mr2022-10-01
- Status last verified
- Nov 2022
- First submitted
- 30 Nov 2022
- Last updated
- 8 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DKI Combined With APT for Post-treatment Assessment of Ovarian Malignancies and Correlation With XRCC2 Gene
- ClinicalTrials.gov ID
- NCT05642871
- Acronym / sponsor ID
- mr2022-10-01
- Conditions
- Malignant Tumor of the Ovary, XRCC2 Gene Mutation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2 participants (estimated)
- Lead sponsor
- Qianqian QuUniversity, hospital or other
- Study start
- 31 Jan 2023 (estimated)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 31 Aug 2025 (estimated)
- First posted
- 8 Dec 2022 (actual)
- 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.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Magnetic Resonance Multifunctional Imaging | – | Radiation: DKI and APT |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with first diagnosis of ovarian malignancy; enrolled patients receive paclitaxel + cisplatin combination chemotherapy in 3-week cycles, with efficacy assessed every 3 cycles
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Recurrent ovarian malignancy; too old, poor physical infrastructure; severe medical comorbidity; incomplete patient data collection; lost to follow-up
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 |
|---|---|---|
| DKI and APTDKI and APT in patients with ovarian malignancy before and after treatment | Radiation | Magnetic Resonance Multifunctional Imaging |
Primary outcome
DKI diffusion indicators and APT signal values
Time frame: 2 Years
MK MD SI
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2022.
- Individual participant dataSharing planned: Undecided
Related trials for Malignant Tumor of the Ovary
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingObservational study
Clonal Hematopoiesis and Therapy-Emergent Myeloid Neoplasms in Patients With Cancers, CHANCES Study
Recurrent Fallopian Tube Carcinoma, Recurrent Ovarian Carcinoma
RecruitingObservational study
Tissue Procurement and Natural History Study of Patients With Malignant Mesothelioma
Thymoma, Stomach Neoplasms
Recruiting
INtegrating Systematic PatIent-Reported Evaluations in Multi-Disciplinary Tumor Boards: The INSPIRE Study
Breast Cancer, Corpus Uteri Cancer
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Malignant Tumor of the Ovary and XRCC2 Gene Mutation, run by Qianqian Qu.
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 1 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 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DKI diffusion indicators and APT signal values (time frame: 2 Years). It is what the study was designed to measure, not a finding.
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 8 Dec 2022.