Solid TumorIMPACTNCT03596593
Identifying MSI Status From ctDNA in Chinese Patients With Refractory Advanced Solid Tumors
A study testing SPANOM (identifying MSI status from ctDNA) in people with Solid Tumor, run by Peking University at 1 site in China.
Trial summary
This is a molecular epidemiological investigation aiming to identify microsatellite instability status from circulating tumor DNA in Chinese patients with refractory advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor
- What is being tested?
- SPANOM (identifying MSI status from ctDNA)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8,000 participants
- Where
- 1 siteChina
- Study dates
- 11 Jul 2018to Jun 2020
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, age≥18 years old.
- Confirmed malignant solid tumor by histopathology or cytopathology.
- Colorectal cancer: progression after second-line therapy. Non-colorectal cancer: progression after first-line therapy.
- Time duration from the last time of anti-cancer treatment to blood sample collection for MSI testing ≥ two weeks or five times half-life period of anti-cancer drugs
- Signed the informed consent with name and time.
Who cannot join
- Hematological malignancy
- Patients who received immuotherapies.
- Patients who received blood transfusion within one month before blood collection.
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
Shen Lin, Professor, 010-88196561, Linshenpku@163.com
Shen Lin, professor
About this study
Official title: Identifying Microsatellite Instability Status From Circulating Tumor DNA in Chinese Patients With Refractory Advanced Solid Tumors: a Large Molecular Epidemiological Investigation
This is a molecular epidemiological investigation aiming to identify microsatellite instability status from circulating tumor DNA in Chinese patients with refractory advanced solid tumors.
Read the detailed description
This study is conducted in Chinese patients with advanced refractory metastatic solid tumors. A total of 8-10 mL of blood will be collected from eligible patients and used for extracting circulating tumor DNA. Blood-MSI status will be tested based on SPANOM technique developed by 3D Medicines Inc. Shanghai, China. Patients are encouraged to provide tissues collected from progressive disease for tissue-MSI testing (not required for inclusion).
- Conditions
- Solid Tumor
- Being tested
- SPANOM (identifying MSI status from ctDNA)
- Keywords
- Solid tumor, China, MSI, ctDNA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPANOM (identifying MSI status from ctDNA)Diagnostic test
SPANOM technique, which has been developed by 3D Medicines Inc. Shanghai, China and made it possible to identify MSI status from blood samples, will be used in patients with refractory advanced solid tumors.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | A total of 8-10 mL of blood will be collected from this group of patients and used for blood-MSI testing. Receives: Diagnostic Test: SPANOM (identifying MSI status from ctDNA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of MSI-H across different cancer types in Chinese patients
Measured: Two years
Secondary outcomes (2)
Incidence of Lynch syndrome across different cancer types
Measured: Two years
Concordance between blood-MSI and corresponding tissue-MSI status
In patients who are able to provide tumor tissue samples, concordance between blood-MSI status by SPANOM technique and tissue-MSI status by polymerase chain reaction (PCR) method will be calculated.
DNA extracted from each tumor tissue will be amplified by standard PCR using six microsatellite loci: NR-21, BA-26, NR-27, BA-25, NR-24, MONO-27. Tumors are designated MSI-H if more than two loci were instable, MSI-L if one locus is instable, and MSS if all loci are stable.
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2018
- Study start11 Jul 2018
- Primary completionJun 2020 (estimated)
- Study completionJun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- More trials run by Peking 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shen Lin, Peking University
- Investigators
- Shen Lin, Professor, Principal investigator, Peking University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03596593
- Sponsor's protocol ID
- IMPACT-China
- Acronym
- IMPACT
- Status last verified
- Jul 2018
- First submitted
- 27 Jun 2018
- Last updated
- 24 Jul 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhenghang Wang, Hao Qin, Mei Wang, et al. SPANOM: A cost-effective method of detecting MSI in ctDNA. ASCO 2018, abstract e24263.
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identifying Microsatellite Instability Status From Circulating Tumor DNA in Chinese Patients With Refractory Advanced Solid Tumors: a Large Molecular Epidemiological Investigation
- ClinicalTrials.gov ID
- NCT03596593
- Acronym / sponsor ID
- IMPACT / IMPACT-China
- Conditions
- Solid Tumor
- Keywords
- Solid tumor, China, MSI, ctDNA
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 8,000 participants (estimated)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Study start
- 11 Jul 2018 (actual)
- Primary completion
- Jun 2020 (estimated)
- Study completion
- Jun 2020 (estimated)
- First posted
- 24 Jul 2018 (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 is a molecular epidemiological investigation aiming to identify microsatellite instability status from circulating tumor DNA in Chinese patients with refractory advanced solid tumors.
Detailed description
This study is conducted in Chinese patients with advanced refractory metastatic solid tumors. A total of 8-10 mL of blood will be collected from eligible patients and used for extracting circulating tumor DNA. Blood-MSI status will be tested based on SPANOM technique developed by 3D Medicines Inc. Shanghai, China. Patients are encouraged to provide tissues collected from progressive disease for tissue-MSI testing (not required for inclusion).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Diagnostic Test: SPANOM (identifying MSI status from ctDNA)A total of 8-10 mL of blood will be collected from this group of patients and used for blood-MSI testing. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female, age≥18 years old.
- Confirmed malignant solid tumor by histopathology or cytopathology.
- Colorectal cancer: progression after second-line therapy. Non-colorectal cancer: progression after first-line therapy.
- Time duration from the last time of anti-cancer treatment to blood sample collection for MSI testing ≥ two weeks or five times half-life period of anti-cancer drugs
- Signed the informed consent with name and time.
Key exclusion criteria (4 listed)
- Hematological malignancy
- Patients who received immuotherapies.
- Patients who received blood transfusion within one month before blood collection.
- Pregnancy.
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 |
|---|---|---|
| SPANOM (identifying MSI status from ctDNA)SPANOM technique, which has been developed by 3D Medicines Inc. Shanghai, China and made it possible to identify MSI status from blood samples, will be used in patients with refractory advanced solid tumors. | Diagnostic test | Experimental group |
Primary outcome
Incidence of MSI-H across different cancer types in Chinese patients
Time frame: Two years
2 secondary outcomes
Incidence of Lynch syndrome across different cancer types
Time frame: Two years
Concordance between blood-MSI and corresponding tissue-MSI status
Time frame: Two years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2018.
- BackgroundZhenghang Wang, Hao Qin, Mei Wang, et al. SPANOM: A cost-effective method of detecting MSI in ctDNA. ASCO 2018, abstract e24263.
- Individual participant dataSharing planned: No
Related trials for Solid Tumor
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
Active, not recruitingPhase 3
A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
Solid Tumors
RecruitingPhase 1
IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
RecruitingObservational study
Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm
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.
Shen Lin, Professor principal investigator
Peking University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SPANOM (identifying MSI status from ctDNA) in people with Solid Tumor, run by Peking 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 5 inclusion and 4 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 24 Jul 2018. 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 Shen Lin, Professor (010-88196561, Linshenpku@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of MSI-H across different cancer types in Chinese patients (time frame: Two 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 NCT03596593, which also lists 1 linked publication.
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 24 Jul 2018.