Nasopharyngeal NeoplasmsNCT02505139
The Value of Diagnosis and Outcome Prediction in CTC for Metastatic NPC Patients
An observational study of Nasopharyngeal Neoplasms, run by Sun Yat-sen University.
Trial summary
A circulating tumor cell (CTC) count is an established prognostic factor in some malignancies such as metastatic breast cancer. However, the value of CTC in diagnosis and outcome prediction of metastatic nasopharyngeal carcinoma (mNPC) patients is not unknown. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Nasopharyngeal Neoplasms
- What is being tested?
- the number of circulating tumor cells
- How many people
- 166 participants
- Where
- No sites listed yet
- Study dates
- Dec 2014to Aug 2016
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: NPC patients with distant metastasis
Who may be able to join
- Histologically or radiologically confirmed nasopharyngeal non-keratinizing carcinoma (WHO II, III).
- NPC patients with distant metastasis including synchronous distant metastasis at diagnosis and metachronous distant metastasis after radical treatment.
- A Karnofsky performance status score more than 70.
- The participants provided written informed consent.
Who cannot join
- A history of previous or synchronous malignant tumors.
- Suffering from severe mental illness synchronously.
- Suffering from severe heart or lung diseases.
- Obvious abnormality in liver and renal function.
- Women in pregnancy or breastfeeding.
About this study
Official title: Using Circulating Tumor Cells to Diagnose and Predict Prognosis in Metastatic Nasopharyngeal Carcinoma Patients
A circulating tumor cell (CTC) count is an established prognostic factor in some malignancies such as metastatic breast cancer. However, the value of CTC in diagnosis and outcome prediction of metastatic nasopharyngeal carcinoma (mNPC) patients is not unknown. Through the observational prospective clinical trial, sensitivity, specificity, positive and negative predictive values of CTC in diagnosis of mNPC patients will be gained. Further, the value of CTC in outcome prediction of mNPC patients will be uncovered.
- Conditions
- Nasopharyngeal Neoplasms
- Being tested
- the number of circulating tumor cells
- Keywords
- nasopharyngeal carcinoma, distant metastasis, circulating tumor cells, outcome prediction
- Medical subject headings
- Nasopharyngeal Neoplasms, Nasopharyngeal Carcinoma, Neoplastic Cells, Circulating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the number of circulating tumor cellsOther
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Not described Receives: Other: the number of circulating tumor cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival rate
Measured: 3 years
Secondary outcomes (4)
The proportion of positives that are correctly identified as such
number of true positives divided by (number of true positives plus number of false negatives)
Measured: 3 years
The proportion of negatives that are correctly identified as such
number of true negatives divided by (number of true negatives plus number of false positives)
Measured: 3 years
The proportions of positive results in statistics and diagnostic tests that are true positive results.
number of true positives divided by number of positive calls
Measured: 3 years
The proportions of negative results in statistics and diagnostic tests that are true negative results.
number of true negatives divided by number of negative calls
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2015 (estimated)
- Study startDec 2014
- Primary completionJul 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Nasopharyngeal NeoplasmsStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 166 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ming-Yuan Chen, Sun Yat-sen University
- Investigators
- Ming-Yuan Chen, MD, PhD, Principal investigator, Sun Yat-Sen University Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02505139
- Sponsor's protocol ID
- SYSUCCCTC
- Status last verified
- Aug 2016
- First submitted
- 20 Jul 2015
- Last updated
- 29 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Smerage JB, Barlow WE, Hortobagyi GN, Winer EP, Leyland-Jones B, Srkalovic G, Tejwani S, Schott AF, O'Rourke MA, Lew DL, Doyle GV, Gralow JR, Livingston RB, Hayes DF. Circulating tumor cells and response to chemotherapy in metastatic breast cancer: SWOG S0500. J Clin Oncol. 2014 Nov 1;32(31):3483-9. doi: 10.1200/JCO.2014.56.2561. Epub 2014 Jun 2.
PubMed 24888818Zhang Z, Shiratsuchi H, Lin J, Chen G, Reddy RM, Azizi E, Fouladdel S, Chang AC, Lin L, Jiang H, Waghray M, Luker G, Simeone DM, Wicha MS, Beer DG, Ramnath N, Nagrath S. Expansion of CTCs from early stage lung cancer patients using a microfluidic co-culture model. Oncotarget. 2014 Dec 15;5(23):12383-97. doi: 10.18632/oncotarget.2592.
PubMed 25474037Cristofanilli M, Hayes DF, Budd GT, Ellis MJ, Stopeck A, Reuben JM, Doyle GV, Matera J, Allard WJ, Miller MC, Fritsche HA, Hortobagyi GN, Terstappen LW. Circulating tumor cells: a novel prognostic factor for newly diagnosed metastatic breast cancer. J Clin Oncol. 2005 Mar 1;23(7):1420-30. doi: 10.1200/JCO.2005.08.140.
PubMed 15735118
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Circulating Tumor Cells to Diagnose and Predict Prognosis in Metastatic Nasopharyngeal Carcinoma Patients
- ClinicalTrials.gov ID
- NCT02505139
- Acronym / sponsor ID
- SYSUCCCTC
- Conditions
- Nasopharyngeal Neoplasms
- Keywords
- nasopharyngeal carcinoma, distant metastasis, circulating tumor cells, outcome prediction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 166 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Jul 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 22 Jul 2015 (estimated)
- 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.
A circulating tumor cell (CTC) count is an established prognostic factor in some malignancies such as metastatic breast cancer. However, the value of CTC in diagnosis and outcome prediction of metastatic nasopharyngeal carcinoma (mNPC) patients is not unknown. Through the observational prospective clinical trial, sensitivity, specificity, positive and negative predictive values of CTC in diagnosis of mNPC patients will be gained. Further, the value of CTC in outcome prediction of mNPC patients will be uncovered.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Group | – | Other: the number of circulating tumor cells |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- NPC patients with distant metastasis
Key inclusion criteria (4 listed)
- Histologically or radiologically confirmed nasopharyngeal non-keratinizing carcinoma (WHO II, III).
- NPC patients with distant metastasis including synchronous distant metastasis at diagnosis and metachronous distant metastasis after radical treatment.
- A Karnofsky performance status score more than 70.
- The participants provided written informed consent.
Key exclusion criteria (5 listed)
- A history of previous or synchronous malignant tumors.
- Suffering from severe mental illness synchronously.
- Suffering from severe heart or lung diseases.
- Obvious abnormality in liver and renal function.
- Women in pregnancy or breastfeeding.
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 |
|---|---|---|
| the number of circulating tumor cells | Other | Study Group |
Primary outcome
Overall survival rate
Time frame: 3 years
4 secondary outcomes
The proportion of positives that are correctly identified as such
Time frame: 3 years
The proportion of negatives that are correctly identified as such
Time frame: 3 years
The proportions of positive results in statistics and diagnostic tests that are true positive results.
Time frame: 3 years
The proportions of negative results in statistics and diagnostic tests that are true negative results.
Time frame: 3 years
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 29 Aug 2016.
- Results publication: PubMed 24888818Smerage JB, Barlow WE, Hortobagyi GN, Winer EP, Leyland-Jones B, Srkalovic G, Tejwani S, Schott AF, O'Rourke MA, Lew DL, Doyle GV, Gralow JR, Livingston RB, Hayes DF. Circulating tumor cells and response to chemotherapy in metastatic breast cancer: SWOG S0500. J Clin Oncol. 2014 Nov 1;32(31):3483-9. doi: 10.1200/JCO.2014.56.2561. Epub 2014 Jun 2.
- Results publication: PubMed 25474037Zhang Z, Shiratsuchi H, Lin J, Chen G, Reddy RM, Azizi E, Fouladdel S, Chang AC, Lin L, Jiang H, Waghray M, Luker G, Simeone DM, Wicha MS, Beer DG, Ramnath N, Nagrath S. Expansion of CTCs from early stage lung cancer patients using a microfluidic co-culture model. Oncotarget. 2014 Dec 15;5(23):12383-97. doi: 10.18632/oncotarget.2592.
- Results publication: PubMed 15735118Cristofanilli M, Hayes DF, Budd GT, Ellis MJ, Stopeck A, Reuben JM, Doyle GV, Matera J, Allard WJ, Miller MC, Fritsche HA, Hortobagyi GN, Terstappen LW. Circulating tumor cells: a novel prognostic factor for newly diagnosed metastatic breast cancer. J Clin Oncol. 2005 Mar 1;23(7):1420-30. doi: 10.1200/JCO.2005.08.140.
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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.
Ming-Yuan Chen, MD, PhD principal investigator
Sun Yat-Sen University Cancer Center
Questions about this trial
What is this clinical trial studying?
An observational study of Nasopharyngeal Neoplasms, run by Sun Yat-sen University.
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: finished, as of the sponsor's last update on 29 Aug 2016. 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?
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?
Overall survival rate (time frame: 3 years). 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 NCT02505139, which also lists 3 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 29 Aug 2016.