Metastasis of Unknown OriginNCT06086652
Role of Positron Emission Tomography in Detecting Primary Tumor in Cases of Metastases of Unknown Origin
An observational study of Metastasis of Unknown Origin, run by Sohag University at 1 site in Egypt.
Trial summary
In most cases of malignancies, the site of origin of the cancer is clear at presentation or identified soon after. However, Metastatic cancer of unknown primary site (MUO) accounts for 3-5% of all malignant neoplasms, and it is defined as metastatic cancer from an unknown primary site, for which no original site can… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastasis of Unknown Origin
- What is being tested?
- PET/CT
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Sep 2023to Dec 2023
- 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 years and older
- All sexes
- Adult, Older adult
Study population: Age > 18 years Patients with metastatic tumor. Primary site was not detected with other radiological examinations Both male and female.
Who may be able to join
- Age > 18 years Patients with metastatic tumor. Primary site was not detected with other radiological examinations Both male and female.
Who cannot join
- Patients with known primary tumor Pregnancy. Age < 18 years.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Sohag university Hospital
Sohag
Magdy M Amin, professor
About this study
In most cases of malignancies, the site of origin of the cancer is clear at presentation or identified soon after. However, Metastatic cancer of unknown primary site (MUO) accounts for 3-5% of all malignant neoplasms, and it is defined as metastatic cancer from an unknown primary site, for which no original site can be detected even after performing all possible tests. Most common metastatic sites include the liver, lymph nodes, lungs, and bones.
18F-fluoro-2-deoxyglucose positron emission tomography (FDG-PET) allows whole-body tumor detection and has proven to be useful in patients with metastasis of unknown primary tumor.
- Conditions
- Metastasis of Unknown Origin
- Being tested
- PET/CT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET/CTDiagnostic test
detection of possible primary tumor
What is being measured
The primary outcome is the main question the study is designed to answer.
primary tumor for metastasis of unknown origin
primary tumor for metastasis of unknown origin
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2023
- Study start15 Sep 2023
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Metastasis of Unknown OriginStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Retrospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Doaa Ibrahim Mohamed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06086652
- Sponsor's protocol ID
- Soh-Med-23-09-2PD
- Status last verified
- Oct 2023
- First submitted
- 11 Oct 2023
- Last updated
- 17 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
van der Strate I, Kazemzadeh F, Nagtegaal ID, Robbrecht D, van de Wouw A, Padilla CS, Duijts S, Esteller M, Greco FA, Pavlidis N, Qaseem A, Snaebjornsson P, van Zanten SV, Loef C. International consensus on the initial diagnostic workup of cancer of unknown primary. Crit Rev Oncol Hematol. 2023 Jan;181:103868. doi: 10.1016/j.critrevonc.2022.103868. Epub 2022 Nov 23.
PubMed 36435296Kwee TC, Kwee RM. Combined FDG-PET/CT for the detection of unknown primary tumors: systematic review and meta-analysis. Eur Radiol. 2009 Mar;19(3):731-44. doi: 10.1007/s00330-008-1194-4. Epub 2008 Oct 17.
PubMed 18925401
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Positron Emission Tomography in Detecting Primary Tumor in Cases of Metastases of Unknown Origin
- ClinicalTrials.gov ID
- NCT06086652
- Acronym / sponsor ID
- Soh-Med-23-09-2PD
- Conditions
- Metastasis of Unknown Origin
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 15 Sep 2023 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 17 Oct 2023 (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.
In most cases of malignancies, the site of origin of the cancer is clear at presentation or identified soon after. However, Metastatic cancer of unknown primary site (MUO) accounts for 3-5% of all malignant neoplasms, and it is defined as metastatic cancer from an unknown primary site, for which no original site can be detected even after performing all possible tests. Most common metastatic sites include the liver, lymph nodes, lungs, and bones.
18F-fluoro-2-deoxyglucose positron emission tomography (FDG-PET) allows whole-body tumor detection and has proven to be useful in patients with metastasis of unknown primary tumor.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Age > 18 years Patients with metastatic tumor. Primary site was not detected with other radiological examinations Both male and female.
Key inclusion criteria (1 listed)
- Age > 18 years Patients with metastatic tumor. Primary site was not detected with other radiological examinations Both male and female.
Key exclusion criteria (1 listed)
- Patients with known primary tumor Pregnancy. Age < 18 years.
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 |
|---|---|---|
| PET/CTdetection of possible primary tumor | Diagnostic test | – |
Primary outcome
primary tumor for metastasis of unknown origin
Time frame: one month
primary tumor for metastasis of unknown origin
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2023.
- Background: PubMed 36435296van der Strate I, Kazemzadeh F, Nagtegaal ID, Robbrecht D, van de Wouw A, Padilla CS, Duijts S, Esteller M, Greco FA, Pavlidis N, Qaseem A, Snaebjornsson P, van Zanten SV, Loef C. International consensus on the initial diagnostic workup of cancer of unknown primary. Crit Rev Oncol Hematol. 2023 Jan;181:103868. doi: 10.1016/j.critrevonc.2022.103868. Epub 2022 Nov 23.
- Background: PubMed 18925401Kwee TC, Kwee RM. Combined FDG-PET/CT for the detection of unknown primary tumors: systematic review and meta-analysis. Eur Radiol. 2009 Mar;19(3):731-44. doi: 10.1007/s00330-008-1194-4. Epub 2008 Oct 17.
- Individual participant dataSharing planned: Undecided
Related trials for Metastasis of Unknown Origin
RecruitingObservational study
Dystonia Genotype-Phenotype Correlation
Dystonia, Dystonia; Idiopathic
Active, not recruitingPhase 2
Donor Peripheral Stem Cell Transplant in Treating Patients With Advanced Hematologic Cancer or Other Disorders
Chronic Myeloproliferative Disorders, Graft Versus Host Disease
RecruitingPhase 1
Phase 1 Study of HBI0101 CAR-T in Refractory B-Cell Autoimmune Diseases
Systemic Sclerosis (SSc), Idiopathic Inflammatory Myopathy (IIM)
RecruitingObservational study
PaCIFiC-CUP Classifies Cancer of Unknown Primary
Unknown Primary Tumors, DNA Methylation
RecruitingObservational study
MPN PROGRESSion Registry: Observational Study Tracking Symptoms, Treatments, and Disease Progression in People With Myeloproliferative Neoplasms (MPNs)
Polycythemia Vera, ET (Essential Thrombocythemia)
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.
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 Metastasis of Unknown Origin, run by Sohag University at 1 site in Egypt.
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 17 Oct 2023. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Doaa I Mohamed, lecturer (01007779485, doaaibrahim@med.soh.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
primary tumor for metastasis of unknown origin (time frame: one month). 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 NCT06086652, which also lists 2 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 17 Oct 2023.