Cancer of Unknown Primary SiteNCT04952103
Real World Study of Diagnosis and First-line Treatment Among Patients With Cancer of Unknown Primary in China
An observational study of Cancer of Unknown Primary Site, run by Fudan University at 1 site in China.
Trial summary
This study is a prospective, real world study.The objective is to observe the diagnosis and first-line treatment of Chinese patients with cancer of unknown primary, and collect the clinicopathological characteristics, treatment outcomes, survival and other data of the patients. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cancer of Unknown Primary Site
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 18 Jun 2021to 18 Jun 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with cancer of unknown primary (CUP) and are gonging to receive the first-line therapy for CUP
Who may be able to join
- Had a diagnosis of cancer of unknown primary (CUP) after a standard evaluation .
- Prepared to receive first-line therapy for CUP
Who cannot join
- Patients who had previously received systemic therapy for CUP
- Previous history of other cancers, except cervix cancer or basal cell carcinoma of the skin that has been cured
- The investigator considered that there were contraindications to treatment or were not appropriate to participate in this study
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cencer Center
Shanghai, Shanghai Municipality, 200032
Zhiguo Luo, MD,PhD, 862164175590 ext. 8908, luozhiguo88@163.com
About this study
This study is a prospective, real world study.The objective is to observe the diagnosis and first-line treatment of Chinese patients with cancer of unknown primary, and collect the clinicopathological characteristics, treatment outcomes, survival and other data of the patients.
- Conditions
- Cancer of Unknown Primary Site
- Being tested
- no intervention
- Medical subject headings
- Neoplasms, Unknown Primary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
The patient's treatment is determined by the physician in charge according to the patient's clinical situation and relevant guidelines, without additional intervention.
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS)
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2021
- Study start18 Jun 2021
- Primary completion18 Jun 2023 (estimated)
- Study completion18 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer of Unknown Primary SiteStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhiguo Luo, MD, PhD, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04952103
- Sponsor's protocol ID
- Fudan-CUP-003
- Status last verified
- Jun 2021
- First submitted
- 30 Jun 2021
- Last updated
- 7 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real World Study of Diagnosis and First-line Treatment Among Patients With Cancer of Unknown Primary in China
- ClinicalTrials.gov ID
- NCT04952103
- Acronym / sponsor ID
- Fudan-CUP-003
- Conditions
- Cancer of Unknown Primary Site
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 18 Jun 2021 (actual)
- Primary completion
- 18 Jun 2023 (estimated)
- Study completion
- 18 Jun 2024 (estimated)
- First posted
- 7 Jul 2021 (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 is a prospective, real world study.The objective is to observe the diagnosis and first-line treatment of Chinese patients with cancer of unknown primary, and collect the clinicopathological characteristics, treatment outcomes, survival and other data of the patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with cancer of unknown primary (CUP) and are gonging to receive the first-line therapy for CUP
Key inclusion criteria (2 listed)
- Had a diagnosis of cancer of unknown primary (CUP) after a standard evaluation .
- Prepared to receive first-line therapy for CUP
Key exclusion criteria (3 listed)
- Patients who had previously received systemic therapy for CUP
- Previous history of other cancers, except cervix cancer or basal cell carcinoma of the skin that has been cured
- The investigator considered that there were contraindications to treatment or were not appropriate to participate in this 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 interventionThe patient's treatment is determined by the physician in charge according to the patient's clinical situation and relevant guidelines, without additional intervention. | Other | – |
Primary outcome
Progression-free survival (PFS)
Time frame: 8 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2021.
- 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.
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 Cancer of Unknown Primary Site, run by Fudan 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 2 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: status not confirmed, as of the sponsor's last update on 7 Jul 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xin Liu (13761503356, jeanettexin@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS) (time frame: 8 months). 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 7 Jul 2021.