Ovarian Cancer, EpithelialNCT06640348
Ultrasensitive SERS Platform With Highly Efficient Enrichment of Analyte for Screening and Diagnosis of Epithelial Ovarian Cancer
An observational study of Ovarian Cancer, Epithelial, run by Anhui Provincial Hospital at 1 site in China.
Trial summary
This project is an open, single-center, prospective study aimed at developing high-sensitivity, high-specificity enrichment SERS chips using femtosecond laser processing technology. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Ovarian Cancer, Epithelial
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2025to 31 Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: The subjects include patients with epithelial ovarian cancer, while the control group consists of patients undergoing surgery for benign diseases.
Who may be able to join
- The subjects understand the trial process, sign the informed consent form, voluntarily participate in the study, and are capable of following the protocol;
- Aged 18 to 70 (inclusive):
- Cancer group: Ovarian cancer patients (50 cases of high-grade serous ovarian cancer, 15 cases of low-grade serous ovarian cancer, 20 cases of endometrioid ovarian cancer, 20 cases of clear cell carcinoma) i. All ovarian cancer patients are initial treatment patients with complete clinical data; ii. Patients have an ECOG performance status score of 0-3 and a life expectancy of more than 6 months; iii. Subjects consent to blood sample collection for SERS analysis (provided free of charge); iv. Good organ function.
- Normal control group: (20 cases) i. Normal control subjects are patients undergoing surgery for benign diseases; ii. Patients have complete clinical data; iii. Subjects have not undergone any radical treatment for the benign lesion prior to blood collection.
Who cannot join
- Severe or uncontrolled diseases, including but not limited to: uncontrollable nausea and vomiting, gastrointestinal diseases that may interfere with drug absorption and metabolism, mental illnesses affecting the patient's ability to sign the informed consent form, a history of severe cardiovascular disease, infectious diseases (such as syphilis, AIDS, active hepatitis C, or active hepatitis B), infectious conditions (such as abscesses), or active rheumatic diseases, etc.;
- A history of blood transfusion within 4 weeks prior to the study;
- Pregnant, postpartum, or breastfeeding patients, or patients planning to become pregnant during the study treatment;
- Patients with a history of other tumors;
- The investigator deems the subject unsuitable for participation in this clinical study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ying Zhou, MD contact
China1 site, 1 recruiting
- Recruiting
Anhui Provincal Hospital
Hefei, Anhui
Ying Zhou, MD, +8613865901025, caddiezy@ustc.edu.cn
About this study
This project is an open, single-center, prospective study aimed at developing high-sensitivity, high-specificity enrichment SERS chips using femtosecond laser processing technology. It involves extracting information from blood samples of ovarian cancer patients and normal controls, specifically identifying cancer and non-cancer signals. The study will construct a statistical algorithm model for the early diagnosis of ovarian cancer, enabling early identification and intervention for ovarian cancer patients.
Read the detailed description
Epithelial Ovarian Cancer (EOC) poses a significant challenge in the field of gynecological oncology regarding precise early screening. In response to this critical scientific issue, the research team has designed and developed a high-sensitivity, high-specificity enrichment SERS chip, exploring its applications in the screening and diagnosis of ovarian cancer. The development of the SERS chip and its functional implementation has been done.Clinical research trials are conducted for ovarian cancer screening and diagnosis, analyzing the physicochemical properties of key biomolecules in the blood of ovarian cancer patients. The study reveals the interaction patterns between SERS active particles and biomolecules, establishing a competitive adsorption model between multiple biomolecules and active particles. Raman spectra of individual components are collected to create a characteristic Raman information database for key biomolecules.
The analysis of Raman spectra from ovarian cancer patients and healthy individuals delves into the characteristic signals, constructing a statistical classification model for patient and normal Raman signals. Different tissue types and grades of ovarian cancer patients' Raman spectra signals are analyzed, establishing high-throughput classification methods for various ovarian cancers. By combining clinical gold-standard detection techniques, the sources of characteristic signals are determined, providing a theoretical foundation and technical support for conducting ovarian cancer research and establishing treatment plans in clinical settings.
- Conditions
- Ovarian Cancer, Epithelial
- Being tested
- No intervention
- Medical subject headings
- Carcinoma, Ovarian Epithelial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| healthy control | By analyzing the Raman signals of peripheral serum from normal controls, unique signal characteristics specific to ovarian cancer patients are identified through comparative analysis with the control group. Receives: Other: No intervention | |
| Ovarian cancer group | Extract information from blood samples of ovarian cancer patients, specifically identifying cancer and non-cancer signals to construct a statistical algorithm model for the early diagnosis of ovarian cancer. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS PFS
progression free survival
Measured: one year
OS
OS (overall survival) is defined as the time which begins at diagnosis and up to the time of death
Measured: three year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start1 Jan 2025 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian Cancer, EpithelialStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anhui Provincial Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06640348
- Sponsor's protocol ID
- YingZhou 2024-10
- Status last verified
- Oct 2024
- First submitted
- 11 Oct 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasensitive SERS Platform With Highly Efficient Enrichment of Analyte for Screening and Diagnosis of Epithelial Ovarian Cancer
- ClinicalTrials.gov ID
- NCT06640348
- Acronym / sponsor ID
- YingZhou 2024-10
- Conditions
- Ovarian Cancer, Epithelial
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Anhui Provincial HospitalOther government
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 15 Oct 2024 (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.
This project is an open, single-center, prospective study aimed at developing high-sensitivity, high-specificity enrichment SERS chips using femtosecond laser processing technology. It involves extracting information from blood samples of ovarian cancer patients and normal controls, specifically identifying cancer and non-cancer signals. The study will construct a statistical algorithm model for the early diagnosis of ovarian cancer, enabling early identification and intervention for ovarian cancer patients.
Detailed description
Epithelial Ovarian Cancer (EOC) poses a significant challenge in the field of gynecological oncology regarding precise early screening. In response to this critical scientific issue, the research team has designed and developed a high-sensitivity, high-specificity enrichment SERS chip, exploring its applications in the screening and diagnosis of ovarian cancer. The development of the SERS chip and its functional implementation has been done.Clinical research trials are conducted for ovarian cancer screening and diagnosis, analyzing the physicochemical properties of key biomolecules in the blood of ovarian cancer patients. The study reveals the interaction patterns between SERS active particles and biomolecules, establishing a competitive adsorption model between multiple biomolecules and active particles. Raman spectra of individual components are collected to create a characteristic Raman information database for key biomolecules.
The analysis of Raman spectra from ovarian cancer patients and healthy individuals delves into the characteristic signals, constructing a statistical classification model for patient and normal Raman signals. Different tissue types and grades of ovarian cancer patients' Raman spectra signals are analyzed, establishing high-throughput classification methods for various ovarian cancers. By combining clinical gold-standard detection techniques, the sources of characteristic signals are determined, providing a theoretical foundation and technical support for conducting ovarian cancer research and establishing treatment plans in clinical settings.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| healthy control | – | Other: No interventionBy analyzing the Raman signals of peripheral serum from normal controls, unique signal characteristics specific to ovarian cancer patients are identified through comparative analysis with the control group. |
| Ovarian cancer group | – | Other: No interventionExtract information from blood samples of ovarian cancer patients, specifically identifying cancer and non-cancer signals to construct a statistical algorithm model for the early diagnosis of ovarian cancer. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The subjects include patients with epithelial ovarian cancer, while the control group consists of patients undergoing surgery for benign diseases.
Key inclusion criteria (4 listed)
- The subjects understand the trial process, sign the informed consent form, voluntarily participate in the study, and are capable of following the protocol;
- Aged 18 to 70 (inclusive):
- Cancer group: Ovarian cancer patients (50 cases of high-grade serous ovarian cancer, 15 cases of low-grade serous ovarian cancer, 20 cases of endometrioid ovarian cancer, 20 cases of clear cell carcinoma) i. All ovarian cancer patients are initial treatment patients with complete clinical data; ii. Patients have an ECOG performance status score of 0-3 and a life expectancy of more than 6 months; iii. Subjects consent to blood sample collection for SERS analysis (provided free of charge); iv. Good organ function.
- Normal control group: (20 cases) i. Normal control subjects are patients undergoing surgery for benign diseases; ii. Patients have complete clinical data; iii. Subjects have not undergone any radical treatment for the benign lesion prior to blood collection.
Key exclusion criteria (5 listed)
- Severe or uncontrolled diseases, including but not limited to: uncontrollable nausea and vomiting, gastrointestinal diseases that may interfere with drug absorption and metabolism, mental illnesses affecting the patient's ability to sign the informed consent form, a history of severe cardiovascular disease, infectious diseases (such as syphilis, AIDS, active hepatitis C, or active hepatitis B), infectious conditions (such as abscesses), or active rheumatic diseases, etc.;
- A history of blood transfusion within 4 weeks prior to the study;
- Pregnant, postpartum, or breastfeeding patients, or patients planning to become pregnant during the study treatment;
- Patients with a history of other tumors;
- The investigator deems the subject unsuitable for participation in this clinical 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 |
|---|---|---|
| No interventionNo intervention | Other | Ovarian cancer group, healthy control |
Primary outcome
PFS PFS
Time frame: one year
progression free survival
OS
Time frame: three year
OS (overall survival) is defined as the time which begins at diagnosis and up to the time of death
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
Related trials for Ovarian Cancer, Epithelial
Active, not recruitingPhase 1
Surgery and Chemotherapy With or Without Chemotherapy After Surgery in Treating Patients With Ovarian, Fallopian Tube, Uterine, or Peritoneal Cancer
FIGO Stage IVA Ovarian Cancer, FIGO Stage IVB Ovarian Cancer
RecruitingObservational study
Solid Tumor Analysis for HLA Loss of Heterozygosity (LOH) and Apheresis for CAR T- Cell Manufacturing
Solid Tumor, Adult, Colorectal Cancer
RecruitingPhase 1
A Phase 1 Study to Evaluate OPB-201 in Recurrent Endometrial and Platinum-resistant Ovarian Cancer.
Endometrial Cancer Recurrent, Endometrial Cancer
RecruitingPhase 2/3
A Study of Raludotatug Deruxtecan (R-DXd) in Subjects With Platinum-resistant, High-grade Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
Solid Cancer
Active, not recruiting
Culturally-Informed Counseling in Latinas at High Risk for Hereditary Breast or Ovarian Cancer
No Evidence of Disease, BRCA1 Syndrome
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.
Ying Zhou, MD contact
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 Ovarian Cancer, Epithelial, run by Anhui Provincial Hospital at 1 site in China.
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 4 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 15 Oct 2024. 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 China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ying Zhou, MD (_8613865901025, caddiezy@ustc.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS PFS (time frame: one year). The study lists 2 primary outcomes in all. 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 15 Oct 2024.