Nasopharyngeal CarcinomaNCT06367049
Methylation-specific PCR Test for Early Screening and Early Diagnosis of Nasopharyngeal Carcinoma
An observational study of Nasopharyngeal Carcinoma and Early Diagnosis of Cancer, run by Sun Yat-sen University at 1 site in China.
Trial summary
Nasopharyngeal carcinoma is one of the most common malignant tumors in China, with the progress of radiochemical comprehensive treatment, early stage The 5-year survival rate of nasopharyngeal cancer is more than 95%. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Nasopharyngeal Carcinoma, Early Diagnosis of Cancer
- What is being tested?
- Methylation-specific PCR
- How many people
- 470 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2023to 1 Mar 2024
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The subjects in the case group (nasopharyngeal carcinoma group) and the control group (non-nasopharyngeal carcinoma group) are from Sun Yat-sen University Cancer Hosptial, Guangdong Women and Children Hospital and Tumor Hospital of Guangzhou Medical College.
Who may be able to join
- Case group (nasopharyngeal carcinoma group): nasopharyngeal carcinoma confirmed by histology or cytology. Control group (non-nasopharyngeal carcinoma group): no nasopharyngeal carcinoma subjects.
- Age ≥18 years and ≤70 years.
- No previous history of other tumors, and no current tumors.
Who cannot join
- Karnofsky score ≤70 points or Zubrod score \>2 points.
- There are serious medical complications, dysfunction of important organs (heart, lung, liver, kidney) or neuropsychiatric disorders.
- Other patients or volunteers deemed unsuitable for inclusion by the supervising physician.
Trial locations and contacts
1 site in 1 country.
About this study
Nasopharyngeal carcinoma is one of the most common malignant tumors in China, with the progress of radiochemical comprehensive treatment, early stage The 5-year survival rate of nasopharyngeal cancer is more than 95%. However, due to the hidden site of nasopharyngeal carcinoma and the lack of obvious early clinical symptoms, more than 70% of the 87,000 newly diagnosed cases each year belong to the advanced stage of nasopharyngeal carcinoma, and the 5-year survival rate of advanced nasopharyngeal carcinoma is only about 70%. Therefore, early screening and diagnosis and early treatment are the key to improve the survival of patients with nasopharyngeal cancer. Selecting a sensitive and accurate biomarker for nasopharyngeal cancer and relying on a simple and feasible examination method for sampling detection will greatly improve the early diagnosis rate of nasopharyngeal cancer.
DNA methylation is a form of chemical modification of DNA that can be done without altering the DNA sequence changes in genetic expression. The main role of DNA methylation is to regulate gene expression. Tumor suppressor genes play the functions of regulating cell differentiation, maturation and programmed death. However, if methylation of promoter region occurs, the expression of tumor suppressor genes is inhibited and the function is lost, resulting in cells remaining in the stage of low differentiation and proliferation, inhibition of apoptosis, formation of blood vessels by cluster cells, loss of cell adhesion, and formation of tumors. It can be seen that DNA methylation occurs in the early stage of tumor, and this biological feature makes it a strong application prospect in early tumor screening.
Read more
There are many methods to detect DNA Methylation, among which methylation-specific PCR (MSP) can easily and quickly determine the methylation status of a specific gene, meeting the affordable, convenient, and easy to generalize characteristics required for screening tests. In combination with previous MSP experiments and previous reports, we found that the methylation levels of promoter fragments of H4C6, Septin9 and RASSF1A genes in nasopharyngeal carcinoma tissues were significantly higher than those in healthy human nasopharyngeal tissues. This suggests that methylation of these three genes may be used as biomarkers for early screening and diagnosis of nasopharyngeal carcinoma.
Therefore, this study intends to detect the methylation status of H4C6, Septin9 and RASSF1A genes based on MSP method with simple operation and low cost. Using clinicopathological diagnosis as the gold standard, the value of this gene methylation index in early screening and early diagnosis of nasopharyngeal cancer was verified, providing a new detection index and method for improving the early diagnosis rate of nasopharyngeal cancer.
- Being tested
- Methylation-specific PCR
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methylation-specific PCRDiagnostic test
Methylation-specific PCR is the simplest and quickest method for qualitative detection of methylation status.
The unmethylated C base is converted to U by bisulfite conversion, which is subsequently amplified by PCR with primers (methylation-specific and non-methylation-specific primers) and subsequently detected by agarose gel electrophoresis or a probe. The key to MSP is to design PCR primers for specific gene regions. The research team of this project has previously found the sequence sites of methylation of H4C6, Septin9 and RASSF1A genes in nasopharyngeal carcinoma tissues through methylation sequencing, and designed specific MSP amplification primers and probes accordingly, which can perform methylation detection easily and quickly.
| Study group | Role | What they receive |
|---|---|---|
| Patient group | Sampling their nasopharyngeal swab specimens and peripheral blood specimens. Receives: Diagnostic Test: Methylation-specific PCR | |
| Non-patient group | Sampling their nasopharyngeal swab specimens and peripheral blood specimens. Receives: Diagnostic Test: Methylation-specific PCR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity
The proportion of patients with pathological diagnosis of nasopharyngeal carcinoma with positive methylation index.
Measured: through study completion, an average of 1 year
Secondary outcomes (1)
Specificity
The proportion of non-nasopharyngeal carcinoma patients with negative methylation index.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2024
- Study start1 Jun 2023
- Primary completion30 Sep 2023
- Study completion1 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Nasopharyngeal CarcinomaStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- 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
- 470 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Collaborators
- Guangdong Women and Children Hospital, Affiliated Cancer Hospital & Institute of Guangzhou Medical University
- Responsible party
- Principal investigator, YiJun Hua, Sun Yat-sen University
- Investigators
- Yi-Jun Hua, Phd, Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06367049
- Sponsor's protocol ID
- 2023-FXY-230-NPC
- Status last verified
- Mar 2024
- First submitted
- 27 Mar 2024
- Last updated
- 16 Apr 2024
- Results posted
- No
- Individual data sharing
- Undecided
Publications
Karimi M, Johansson S, Stach D, Corcoran M, Grander D, Schalling M, Bakalkin G, Lyko F, Larsson C, Ekstrom TJ. LUMA (LUminometric Methylation Assay)--a high throughput method to the analysis of genomic DNA methylation. Exp Cell Res. 2006 Jul 1;312(11):1989-95. doi: 10.1016/j.yexcr.2006.03.006. Epub 2006 Apr 19.
PubMed 16624287Lyu JY, Chen JY, Zhang XJ, Zhang MW, Yu GS, Zhang L, Wen Z. Septin 9 Methylation in Nasopharyngeal Swabs: A Potential Minimally Invasive Biomarker for the Early Detection of Nasopharyngeal Carcinoma. Dis Markers. 2020 May 5;2020:7253531. doi: 10.1155/2020/7253531. eCollection 2020.
PubMed 32454907Chang HW, Chan A, Kwong DL, Wei WI, Sham JS, Yuen AP. Evaluation of hypermethylated tumor suppressor genes as tumor markers in mouth and throat rinsing fluid, nasopharyngeal swab and peripheral blood of nasopharygeal carcinoma patient. Int J Cancer. 2003 Jul 20;105(6):851-5. doi: 10.1002/ijc.11162.
PubMed 12767073Wong TS, Kwong DL, Sham JS, Wei WI, Kwong YL, Yuen AP. Quantitative plasma hypermethylated DNA markers of undifferentiated nasopharyngeal carcinoma. Clin Cancer Res. 2004 Apr 1;10(7):2401-6. doi: 10.1158/1078-0432.ccr-03-0139.
PubMed 15073117Hutajulu SH, Indrasari SR, Indrawati LP, Harijadi A, Duin S, Haryana SM, Steenbergen RD, Greijer AE, Middeldorp JM. Epigenetic markers for early detection of nasopharyngeal carcinoma in a high risk population. Mol Cancer. 2011 May 2;10:48. doi: 10.1186/1476-4598-10-48.
PubMed 21535891Ye M, Huang T, Ni C, Yang P, Chen S. Diagnostic Capacity of RASSF1A Promoter Methylation as a Biomarker in Tissue, Brushing, and Blood Samples of Nasopharyngeal Carcinoma. EBioMedicine. 2017 Apr;18:32-40. doi: 10.1016/j.ebiom.2017.03.038. Epub 2017 Apr 2.
PubMed 28396012Li Y, Yang X, Du X, Lei Y, He Q, Hong X, Tang X, Wen X, Zhang P, Sun Y, Zhang J, Wang Y, Ma J, Liu N. RAB37 Hypermethylation Regulates Metastasis and Resistance to Docetaxel-Based Induction Chemotherapy in Nasopharyngeal Carcinoma. Clin Cancer Res. 2018 Dec 15;24(24):6495-6508. doi: 10.1158/1078-0432.CCR-18-0532. Epub 2018 Aug 21.
PubMed 30131385Shi F, Zhou M, Shang L, Du Q, Li Y, Xie L, Liu X, Tang M, Luo X, Fan J, Zhou J, Gao Q, Qiu S, Wu W, Zhang X, Bode AM, Cao Y. EBV(LMP1)-induced metabolic reprogramming inhibits necroptosis through the hypermethylation of the RIP3 promoter. Theranostics. 2019 Apr 13;9(9):2424-2438. doi: 10.7150/thno.30941. eCollection 2019.
PubMed 31131045Zhao Y, Hong XH, Li K, Li YQ, Li YQ, He SW, Zhang PP, Li JY, Li Q, Liang YL, Chen Y, Ma J, Liu N, Chen YP. ZNF582 hypermethylation promotes metastasis of nasopharyngeal carcinoma by regulating the transcription of adhesion molecules Nectin-3 and NRXN3. Cancer Commun (Lond). 2020 Dec;40(12):721-737. doi: 10.1002/cac2.12104. Epub 2020 Oct 10.
PubMed 33038291Chen Y, Zhao Y, Yang X, Ren X, Huang S, Gong S, Tan X, Li J, He S, Li Y, Hong X, Li Q, Ding C, Fang X, Ma J, Liu N. USP44 regulates irradiation-induced DNA double-strand break repair and suppresses tumorigenesis in nasopharyngeal carcinoma. Nat Commun. 2022 Jan 25;13(1):501. doi: 10.1038/s41467-022-28158-2.
PubMed 35079021Papanicolau-Sengos A, Aldape K. DNA Methylation Profiling: An Emerging Paradigm for Cancer Diagnosis. Annu Rev Pathol. 2022 Jan 24;17:295-321. doi: 10.1146/annurev-pathol-042220-022304. Epub 2021 Nov 4.
PubMed 34736341Roy D, Tiirikainen M. Diagnostic Power of DNA Methylation Classifiers for Early Detection of Cancer. Trends Cancer. 2020 Feb;6(2):78-81. doi: 10.1016/j.trecan.2019.12.006. Epub 2020 Feb 3.
PubMed 32061307Widschwendter M, Zikan M, Wahl B, Lempiainen H, Paprotka T, Evans I, Jones A, Ghazali S, Reisel D, Eichner J, Rujan T, Yang Z, Teschendorff AE, Ryan A, Cibula D, Menon U, Wittenberger T. The potential of circulating tumor DNA methylation analysis for the early detection and management of ovarian cancer. Genome Med. 2017 Dec 22;9(1):116. doi: 10.1186/s13073-017-0500-7.
PubMed 29268796Sung CK, Yim H. CRISPR-mediated promoter de/methylation technologies for gene regulation. Arch Pharm Res. 2020 Jul;43(7):705-713. doi: 10.1007/s12272-020-01257-8. Epub 2020 Jul 28.
PubMed 32725389Mattei AL, Bailly N, Meissner A. DNA methylation: a historical perspective. Trends Genet. 2022 Jul;38(7):676-707. doi: 10.1016/j.tig.2022.03.010. Epub 2022 Apr 30.
PubMed 35504755
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Methylation-specific PCR Test for Early Screening and Early Diagnosis of Nasopharyngeal Carcinoma
- ClinicalTrials.gov ID
- NCT06367049
- Acronym / sponsor ID
- 2023-FXY-230-NPC
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 470 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- Guangdong Women and Children Hospital, Affiliated Cancer Hospital & Institute of Guangzhou Medical University
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 16 Apr 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.
Nasopharyngeal carcinoma is one of the most common malignant tumors in China, with the progress of radiochemical comprehensive treatment, early stage The 5-year survival rate of nasopharyngeal cancer is more than 95%. However, due to the hidden site of nasopharyngeal carcinoma and the lack of obvious early clinical symptoms, more than 70% of the 87,000 newly diagnosed cases each year belong to the advanced stage of nasopharyngeal carcinoma, and the 5-year survival rate of advanced nasopharyngeal carcinoma is only about 70%. Therefore, early screening and diagnosis and early treatment are the key to improve the survival of patients with nasopharyngeal cancer. Selecting a sensitive and accurate biomarker for nasopharyngeal cancer and relying on a simple and feasible examination method for sampling detection will greatly improve the early diagnosis rate of nasopharyngeal cancer.
DNA methylation is a form of chemical modification of DNA that can be done without altering the DNA sequence changes in genetic expression. The main role of DNA methylation is to regulate gene expression. Tumor suppressor genes play the functions of regulating cell differentiation, maturation and programmed death. However, if methylation of promoter region occurs, the expression of tumor suppressor genes is inhibited and the function is lost, resulting in cells remaining in the stage of low differentiation and proliferation, inhibition of apoptosis, formation of blood vessels by cluster cells, loss of cell adhesion, and formation of tumors. It can be seen that DNA methylation occurs in the early stage of tumor, and this biological feature makes it a strong application prospect in early tumor screening.
There are many methods to detect DNA Methylation, among which methylation-specific PCR (MSP) can easily and quickly determine the methylation status of a specific gene, meeting the affordable, convenient, and easy to generalize characteristics required for screening tests. In combination with previous MSP experiments and previous reports, we found that the methylation levels of promoter fragments of H4C6, Septin9 and RASSF1A genes in nasopharyngeal carcinoma tissues were significantly higher than those in healthy human nasopharyngeal tissues. This suggests that methylation of these three genes may be used as biomarkers for early screening and diagnosis of nasopharyngeal carcinoma.
Therefore, this study intends to detect the methylation status of H4C6, Septin9 and RASSF1A genes based on MSP method with simple operation and low cost. Using clinicopathological diagnosis as the gold standard, the value of this gene methylation index in early screening and early diagnosis of nasopharyngeal cancer was verified, providing a new detection index and method for improving the early diagnosis rate of nasopharyngeal cancer.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient group | – | Diagnostic Test: Methylation-specific PCRSampling their nasopharyngeal swab specimens and peripheral blood specimens. |
| Non-patient group | – | Diagnostic Test: Methylation-specific PCRSampling their nasopharyngeal swab specimens and peripheral blood specimens. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The subjects in the case group (nasopharyngeal carcinoma group) and the control group (non-nasopharyngeal carcinoma group) are from Sun Yat-sen University Cancer Hosptial, Guangdong Women and Children Hospital and Tumor Hospital of Guangzhou Medical College.
Key inclusion criteria (3 listed)
- Case group (nasopharyngeal carcinoma group): nasopharyngeal carcinoma confirmed by histology or cytology. Control group (non-nasopharyngeal carcinoma group): no nasopharyngeal carcinoma subjects.
- Age ≥18 years and ≤70 years.
- No previous history of other tumors, and no current tumors.
Key exclusion criteria (3 listed)
- Karnofsky score ≤70 points or Zubrod score \>2 points.
- There are serious medical complications, dysfunction of important organs (heart, lung, liver, kidney) or neuropsychiatric disorders.
- Other patients or volunteers deemed unsuitable for inclusion by the supervising physician.
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 |
|---|---|---|
| Methylation-specific PCRMethylation-specific PCR is the simplest and quickest method for qualitative detection of methylation status. The unmethylated C base is converted to U by bisulfite conversion, which is subsequently amplified by PCR with primers (methylation-specific and non-methylation-specific primers) and subsequently detected by agarose gel electrophoresis or a probe. The key to MSP is to design PCR primers for specific gene regions. The research team of this project has previously found the sequence sites of methylation of H4C6, Septin9 and RASSF1A genes in nasopharyngeal carcinoma tissues through methylation sequencing, and designed specific MSP amplification primers and probes accordingly, which can perform methylation detection easily and quickly. | Diagnostic test | Non-patient group, Patient group |
Primary outcome
Sensitivity
Time frame: through study completion, an average of 1 year
The proportion of patients with pathological diagnosis of nasopharyngeal carcinoma with positive methylation index.
1 secondary outcome
Specificity
Time frame: through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2024.
- Background: PubMed 16624287Karimi M, Johansson S, Stach D, Corcoran M, Grander D, Schalling M, Bakalkin G, Lyko F, Larsson C, Ekstrom TJ. LUMA (LUminometric Methylation Assay)--a high throughput method to the analysis of genomic DNA methylation. Exp Cell Res. 2006 Jul 1;312(11):1989-95. doi: 10.1016/j.yexcr.2006.03.006. Epub 2006 Apr 19.
- Background: PubMed 32454907Lyu JY, Chen JY, Zhang XJ, Zhang MW, Yu GS, Zhang L, Wen Z. Septin 9 Methylation in Nasopharyngeal Swabs: A Potential Minimally Invasive Biomarker for the Early Detection of Nasopharyngeal Carcinoma. Dis Markers. 2020 May 5;2020:7253531. doi: 10.1155/2020/7253531. eCollection 2020.
- Background: PubMed 12767073Chang HW, Chan A, Kwong DL, Wei WI, Sham JS, Yuen AP. Evaluation of hypermethylated tumor suppressor genes as tumor markers in mouth and throat rinsing fluid, nasopharyngeal swab and peripheral blood of nasopharygeal carcinoma patient. Int J Cancer. 2003 Jul 20;105(6):851-5. doi: 10.1002/ijc.11162.
- Background: PubMed 15073117Wong TS, Kwong DL, Sham JS, Wei WI, Kwong YL, Yuen AP. Quantitative plasma hypermethylated DNA markers of undifferentiated nasopharyngeal carcinoma. Clin Cancer Res. 2004 Apr 1;10(7):2401-6. doi: 10.1158/1078-0432.ccr-03-0139.
- Background: PubMed 21535891Hutajulu SH, Indrasari SR, Indrawati LP, Harijadi A, Duin S, Haryana SM, Steenbergen RD, Greijer AE, Middeldorp JM. Epigenetic markers for early detection of nasopharyngeal carcinoma in a high risk population. Mol Cancer. 2011 May 2;10:48. doi: 10.1186/1476-4598-10-48.
- Background: PubMed 28396012Ye M, Huang T, Ni C, Yang P, Chen S. Diagnostic Capacity of RASSF1A Promoter Methylation as a Biomarker in Tissue, Brushing, and Blood Samples of Nasopharyngeal Carcinoma. EBioMedicine. 2017 Apr;18:32-40. doi: 10.1016/j.ebiom.2017.03.038. Epub 2017 Apr 2.
- Background: PubMed 30131385Li Y, Yang X, Du X, Lei Y, He Q, Hong X, Tang X, Wen X, Zhang P, Sun Y, Zhang J, Wang Y, Ma J, Liu N. RAB37 Hypermethylation Regulates Metastasis and Resistance to Docetaxel-Based Induction Chemotherapy in Nasopharyngeal Carcinoma. Clin Cancer Res. 2018 Dec 15;24(24):6495-6508. doi: 10.1158/1078-0432.CCR-18-0532. Epub 2018 Aug 21.
- Background: PubMed 31131045Shi F, Zhou M, Shang L, Du Q, Li Y, Xie L, Liu X, Tang M, Luo X, Fan J, Zhou J, Gao Q, Qiu S, Wu W, Zhang X, Bode AM, Cao Y. EBV(LMP1)-induced metabolic reprogramming inhibits necroptosis through the hypermethylation of the RIP3 promoter. Theranostics. 2019 Apr 13;9(9):2424-2438. doi: 10.7150/thno.30941. eCollection 2019.
- Background: PubMed 33038291Zhao Y, Hong XH, Li K, Li YQ, Li YQ, He SW, Zhang PP, Li JY, Li Q, Liang YL, Chen Y, Ma J, Liu N, Chen YP. ZNF582 hypermethylation promotes metastasis of nasopharyngeal carcinoma by regulating the transcription of adhesion molecules Nectin-3 and NRXN3. Cancer Commun (Lond). 2020 Dec;40(12):721-737. doi: 10.1002/cac2.12104. Epub 2020 Oct 10.
- Background: PubMed 35079021Chen Y, Zhao Y, Yang X, Ren X, Huang S, Gong S, Tan X, Li J, He S, Li Y, Hong X, Li Q, Ding C, Fang X, Ma J, Liu N. USP44 regulates irradiation-induced DNA double-strand break repair and suppresses tumorigenesis in nasopharyngeal carcinoma. Nat Commun. 2022 Jan 25;13(1):501. doi: 10.1038/s41467-022-28158-2.
- Background: PubMed 34736341Papanicolau-Sengos A, Aldape K. DNA Methylation Profiling: An Emerging Paradigm for Cancer Diagnosis. Annu Rev Pathol. 2022 Jan 24;17:295-321. doi: 10.1146/annurev-pathol-042220-022304. Epub 2021 Nov 4.
- Background: PubMed 32061307Roy D, Tiirikainen M. Diagnostic Power of DNA Methylation Classifiers for Early Detection of Cancer. Trends Cancer. 2020 Feb;6(2):78-81. doi: 10.1016/j.trecan.2019.12.006. Epub 2020 Feb 3.
- Individual participant dataSharing planned: Undecided
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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.
Yi-Jun Hua, Phd principal investigator
Sun Yat-sen University
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 Nasopharyngeal Carcinoma and Early Diagnosis of Cancer, run by Sun Yat-sen University 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 3 inclusion and 3 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: finished, as of the sponsor's last update on 16 Apr 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Sensitivity (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06367049, which also lists 21 linked publications.
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 16 Apr 2024.