Malignant Tumor With MetastasisNCT07319949
Evaluating the Predictive Capability of Transcriptomic Profiling for Identifying the Primary Site of Metastatic Tumors
An observational study of Malignant Tumor With Metastasis and CUP, run by Fudan University.
Trial summary
This study will enroll patients with metastatic malignancies. Tumor samples (fresh or formalin-fixed paraffin-embedded tissue specimens) will undergo RNA extraction and next-generation sequencing (RNA-seq). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Malignant Tumor With Metastasis, CUP
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 15 Jan 2026to 13 Oct 2026
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients treated in Fudan University Shanghai Cancer Center, encompassing both outpatient and inpatient populations.
Who may be able to join
- Clinically confirmed diagnosis of malignant tumor with metastasis;
- Metastatic lesions confirmed as malignant by histopathology;
- Sufficient surgical resection or biopsy specimens retained to meet the requirements for next-generation sequencing;
- The participant (or their legal representative/guardian) has signed the informed consent form, confirming full understanding of the study's purpose and procedures, and voluntarily agrees to participate.
Who cannot join
- 1. The investigator deems the patient unable to provide informed consent.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluative Study on Predicting the Primary Site of Metastatic Tumors Using Transcriptomic Profiling for Tumor Tissue Origin Identification
This study will enroll patients with metastatic malignancies. Tumor samples (fresh or formalin-fixed paraffin-embedded tissue specimens) will undergo RNA extraction and next-generation sequencing (RNA-seq). Once the raw data is obtained, the system will analyze the transcriptomic feature values (cancer-specific RNA transcripts and tissue-specific RNA transcripts) expressed in the tumor tissue samples to further predict tissue origin using a machine learning model. The output includes probabilities and confidence intervals for tissue origin.
Read the detailed description
This is a non-interventional, observational study. Through a single-center, prospective clinical trial, the study aims to utilize the transcriptomic profiling for tumor tissue origin identification to predict the tissue origin of primary sites in metastatic tumors and evaluate the accuracy and specificity of this prediction solution.
Primary Endpoint:
The accuracy of the transcriptomic profiling for tumor tissue origin identification in predicting the primary site of metastatic tumors (expressed as overall accuracy with its 95% confidence interval).
Secondary Endpoints:
- The specificity and sensitivity of the transcriptomic profiling for tumor tissue origin identification in predicting the primary site of metastatic tumors.
- Exploratory analysis of characteristic molecular markers expressed in metastatic lesions from different primary sites.
- Conditions
- Malignant Tumor With Metastasis, CUP
- Keywords
- Cancer of unknown primary, Specific RNA transcript, Tissue origin identification, Machine learning, Cancer diagnosis
What is being measured
The primary outcome is the main question the study is designed to answer.
The accuracy of the transcriptomic profiling for tumor tissue origin identification in predicting the primary site of metastatic tumors
Overall accuracy of the tumor tissue origin tracing transcriptome test for predicting the primary site of metastatic tumors (number of correct predictions/total evaluable cases); Specificity [true negatives/(true negatives + false positives)]; Sensitivity [true positives/(true positives + false negatives)].
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 posted6 Jan 2026
- Study start15 Jan 2026 (estimated)
- Primary completion13 Oct 2026 (estimated)
- Study completion13 Oct 2026 (estimated)
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 Malignant Tumor With MetastasisStudies of the same condition, open and under way.
- More trials run by Fudan 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 only
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhimin Shao, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07319949
- Sponsor's protocol ID
- SRTCD-NO001
- Status last verified
- Dec 2025
- First submitted
- 8 Dec 2025
- Last updated
- 6 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shi Q, Li X, Liu Y, Chen Z, He X. FLIBase: a comprehensive repository of full-length isoforms across human cancers and tissues. Nucleic Acids Res. 2024 Jan 5;52(D1):D124-D133. doi: 10.1093/nar/gkad745.
PubMed 37697439Shi Q, Liu T, Hu W, Chen Z, He X, Li S. SRTdb: an omnibus for human tissue and cancer-specific RNA transcripts. Biomark Res. 2022 Apr 26;10(1):27. doi: 10.1186/s40364-022-00377-1.
PubMed 35473935Lee MS, Sanoff HK. Cancer of unknown primary. BMJ. 2020 Dec 7;371:m4050. doi: 10.1136/bmj.m4050.
PubMed 33288500
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluative Study on Predicting the Primary Site of Metastatic Tumors Using Transcriptomic Profiling for Tumor Tissue Origin Identification
- ClinicalTrials.gov ID
- NCT07319949
- Acronym / sponsor ID
- SRTCD-NO001
- Conditions
- Malignant Tumor With Metastasis, CUP
- Keywords
- Cancer of unknown primary, Specific RNA transcript, Tissue origin identification, Machine learning, Cancer diagnosis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 15 Jan 2026 (estimated)
- Primary completion
- 13 Oct 2026 (estimated)
- Study completion
- 13 Oct 2026 (estimated)
- First posted
- 6 Jan 2026 (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 study will enroll patients with metastatic malignancies. Tumor samples (fresh or formalin-fixed paraffin-embedded tissue specimens) will undergo RNA extraction and next-generation sequencing (RNA-seq). Once the raw data is obtained, the system will analyze the transcriptomic feature values (cancer-specific RNA transcripts and tissue-specific RNA transcripts) expressed in the tumor tissue samples to further predict tissue origin using a machine learning model. The output includes probabilities and confidence intervals for tissue origin.
Detailed description
This is a non-interventional, observational study. Through a single-center, prospective clinical trial, the study aims to utilize the transcriptomic profiling for tumor tissue origin identification to predict the tissue origin of primary sites in metastatic tumors and evaluate the accuracy and specificity of this prediction solution.
Primary Endpoint:
The accuracy of the transcriptomic profiling for tumor tissue origin identification in predicting the primary site of metastatic tumors (expressed as overall accuracy with its 95% confidence interval).
Secondary Endpoints:
- The specificity and sensitivity of the transcriptomic profiling for tumor tissue origin identification in predicting the primary site of metastatic tumors.
- Exploratory analysis of characteristic molecular markers expressed in metastatic lesions from different primary sites.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients treated in Fudan University Shanghai Cancer Center, encompassing both outpatient and inpatient populations.
Key inclusion criteria (4 listed)
- Clinically confirmed diagnosis of malignant tumor with metastasis;
- Metastatic lesions confirmed as malignant by histopathology;
- Sufficient surgical resection or biopsy specimens retained to meet the requirements for next-generation sequencing;
- The participant (or their legal representative/guardian) has signed the informed consent form, confirming full understanding of the study's purpose and procedures, and voluntarily agrees to participate.
Key exclusion criteria (1 listed)
- 1. The investigator deems the patient unable to provide informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The accuracy of the transcriptomic profiling for tumor tissue origin identification in predicting the primary site of metastatic tumors
Time frame: through study completion, an average of 1 year
Overall accuracy of the tumor tissue origin tracing transcriptome test for predicting the primary site of metastatic tumors (number of correct predictions/total evaluable cases); Specificity [true negatives/(true negatives + false positives)]; Sensitivity [true positives/(true positives + false negatives)].
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 6 Jan 2026.
- Background: PubMed 37697439Shi Q, Li X, Liu Y, Chen Z, He X. FLIBase: a comprehensive repository of full-length isoforms across human cancers and tissues. Nucleic Acids Res. 2024 Jan 5;52(D1):D124-D133. doi: 10.1093/nar/gkad745.
- Background: PubMed 35473935Shi Q, Liu T, Hu W, Chen Z, He X, Li S. SRTdb: an omnibus for human tissue and cancer-specific RNA transcripts. Biomark Res. 2022 Apr 26;10(1):27. doi: 10.1186/s40364-022-00377-1.
- Background: PubMed 33288500Lee MS, Sanoff HK. Cancer of unknown primary. BMJ. 2020 Dec 7;371:m4050. doi: 10.1136/bmj.m4050.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Malignant Tumor With Metastasis and CUP, run by Fudan 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 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: opening soon, as of the sponsor's last update on 6 Jan 2026. 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?
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 Zhiao Chen, Ph.D. (008618017312074, zachen@fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The accuracy of the transcriptomic profiling for tumor tissue origin identification in predicting the primary site of metastatic tumors (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 NCT07319949, 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 6 Jan 2026.