Early DiagnosisNCT03882684
Role of Genomic Imprinting in Cancer Diagnosis
An observational study of Early Diagnosis and Cancer, run by Chinese Alliance Against Lung Cancer at 1 site in China.
Trial summary
The current research focus for cancer diagonosis is classical genetics, named "driving genes". However, not all cancer patients have typical genetic alterations, especially at early stage. In the past dacades, accumulating evidences have revealed that more than 80% diseases are closely related to epigenetic changes. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Early Diagnosis, Cancer, Biomarker
- What is being tested?
- In-situ imprinting detection
- How many people
- 1,500 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2017to 30 Jun 2020
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients diagnosed with suspicious cancer in Zhongshan Hospital from July 2017 till the end of this study.
Who may be able to join
- Patients diagnosed with suspicious cancer by ultrasound, CT or endoscope.
- Biopsy samples available.
- Male or female patients aged ≥ 18 years.
- Participants signed informed consent form.
Who cannot join
- Age under 18 years.
- Severe cardiovascular diseases.
- Central nervous system diseases.
- Mental disorder.
- Pregnant.
- Individuals unwilling to sign the IRB-approved consent form and unwilling to follow the protocol to submit the serial urine for test after surgery.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongshan Hospital of Fudan University
Shanghai, Shanghai Municipality, 200000
Chunxue Bai, MD, 18621170011, bai.chunxue@zs-hospital.sh.cn
Dawei Yang, MD, 13564703813, yang_dw@hotmail.com
About this study
The current research focus for cancer diagonosis is classical genetics, named "driving genes". However, not all cancer patients have typical genetic alterations, especially at early stage. In the past dacades, accumulating evidences have revealed that more than 80% diseases are closely related to epigenetic changes. The normally silenced copy of imprinted genes are reactivated at early stage of cancers, and finally proceed to copy number variation. This study will screen for a panel of imprinted genes and build quantitative models to assist the diagnosis of multiple cancers.
- Conditions
- Early Diagnosis, Cancer, Biomarker, Genomic Imprinting
- Being tested
- In-situ imprinting detection
- Medical subject headings
- Disease, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In-situ imprinting detectionDiagnostic test
The loss of imprinting (LOI) and copy number variation (CNV) from biopsies will be tested by LiSen in-situ imprinting detection.
| Study group | Role | What they receive |
|---|---|---|
| Cancer patients | The patients receive the surgery according to the indication of surgery. The diagnosis is confirmed by pathology of removed tissue. The result of imprinting detection are used as cancer group. Receives: Diagnostic Test: In-situ imprinting detection | |
| Benign tumor and other disease patients | Patients ruled out the possibility of malignancy according to biopsy pathology are used as negative control. Receives: Diagnostic Test: In-situ imprinting detection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of imprinting cancer early detection
Number of patients "declared positive" with the imprinting early detection among the patients suffered from cancer
Measured: In the middle of the study, an average of 15 months
Specificity of imprinting cancer early detection
Number of patients "declared negative" with the imprinting early detection among the patients who are with benign tumors or other diseases
Measured: In the middle of the study, an average of 15 months
Secondary outcomes (2)
Comparison of the sensitivity of the imprinting detection versus cytopathology
Number of patients "declared positive" with the imprinting early detection versus patients "declared positive" with the cytopathology
Measured: In the middle of the study, an average of 15 months
Comparison of the specificity of the imprinting detection versus cytopathology
Number of patients "declared negative" with the imprinting early detection versus patients "declared negative" with the cytopathology
Measured: In the middle of the study, an average of 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2019
- Study start1 Jul 2017
- Primary completion31 Mar 2019 (estimated)
- Study completion30 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Early DiagnosisStudies of the same condition, open and under way.
- 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-control
- Time perspective
- Retrospective
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese Alliance Against Lung Cancer
- Sponsor type
- University, hospital or other
- Collaborators
- LiSen Imprinting Diagnostic Inc.
- Responsible party
- Principal investigator, Bai Chunxue, Chinese Alliance Against Lung Cancer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03882684
- Sponsor's protocol ID
- CAALC-005-LiSen
- Status last verified
- Mar 2019
- First submitted
- 18 Mar 2019
- Last updated
- 20 Mar 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Feinberg AP. The Key Role of Epigenetics in Human Disease Prevention and Mitigation. N Engl J Med. 2018 Apr 5;378(14):1323-1334. doi: 10.1056/NEJMra1402513. No abstract available.
PubMed 29617578Jelinic P, Shaw P. Loss of imprinting and cancer. J Pathol. 2007 Feb;211(3):261-8. doi: 10.1002/path.2116.
PubMed 17177177Haig D. Maternal-fetal conflict, genomic imprinting and mammalian vulnerabilities to cancer. Philos Trans R Soc Lond B Biol Sci. 2015 Jul 19;370(1673):20140178. doi: 10.1098/rstb.2014.0178.
PubMed 26056362Nilendu P, Sharma NK. Epigenomic Hard Drive Imprinting: A Hidden Code Beyond the Biological Death of Cancer Patients. J Cancer Prev. 2017 Dec;22(4):211-218. doi: 10.15430/JCP.2017.22.4.211. Epub 2017 Dec 30.
PubMed 29302578Uribe-Lewis S, Woodfine K, Stojic L, Murrell A. Molecular mechanisms of genomic imprinting and clinical implications for cancer. Expert Rev Mol Med. 2011 Jan 25;13:e2. doi: 10.1017/S1462399410001717.
PubMed 21262060
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Genomic Imprinting in Cancer Diagnosis
- ClinicalTrials.gov ID
- NCT03882684
- Acronym / sponsor ID
- CAALC-005-LiSen
- Conditions
- Early Diagnosis, Cancer, Biomarker, Genomic Imprinting
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Chinese Alliance Against Lung CancerUniversity, hospital or other
- Collaborators
- LiSen Imprinting Diagnostic Inc.
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 31 Mar 2019 (estimated)
- Study completion
- 30 Jun 2020 (estimated)
- First posted
- 20 Mar 2019 (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.
The current research focus for cancer diagonosis is classical genetics, named "driving genes". However, not all cancer patients have typical genetic alterations, especially at early stage. In the past dacades, accumulating evidences have revealed that more than 80% diseases are closely related to epigenetic changes. The normally silenced copy of imprinted genes are reactivated at early stage of cancers, and finally proceed to copy number variation. This study will screen for a panel of imprinted genes and build quantitative models to assist the diagnosis of multiple cancers.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cancer patients | – | Diagnostic Test: In-situ imprinting detectionThe patients receive the surgery according to the indication of surgery. The diagnosis is confirmed by pathology of removed tissue. The result of imprinting detection are used as cancer group. |
| Benign tumor and other disease patients | – | Diagnostic Test: In-situ imprinting detectionPatients ruled out the possibility of malignancy according to biopsy pathology are used as negative control. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with suspicious cancer in Zhongshan Hospital from July 2017 till the end of this study.
Key inclusion criteria (4 listed)
- Patients diagnosed with suspicious cancer by ultrasound, CT or endoscope.
- Biopsy samples available.
- Male or female patients aged ≥ 18 years.
- Participants signed informed consent form.
Key exclusion criteria (6 listed)
- Age under 18 years.
- Severe cardiovascular diseases.
- Central nervous system diseases.
- Mental disorder.
- Pregnant.
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 |
|---|---|---|
| In-situ imprinting detectionThe loss of imprinting (LOI) and copy number variation (CNV) from biopsies will be tested by LiSen in-situ imprinting detection. | Diagnostic test | Benign tumor and other disease patients, Cancer patients |
Primary outcome
Sensitivity of imprinting cancer early detection
Time frame: In the middle of the study, an average of 15 months
Number of patients "declared positive" with the imprinting early detection among the patients suffered from cancer
Specificity of imprinting cancer early detection
Time frame: In the middle of the study, an average of 15 months
Number of patients "declared negative" with the imprinting early detection among the patients who are with benign tumors or other diseases
2 secondary outcomes
Comparison of the sensitivity of the imprinting detection versus cytopathology
Time frame: In the middle of the study, an average of 15 months
Comparison of the specificity of the imprinting detection versus cytopathology
Time frame: In the middle of the study, an average of 15 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2019.
- Background: PubMed 29617578Feinberg AP. The Key Role of Epigenetics in Human Disease Prevention and Mitigation. N Engl J Med. 2018 Apr 5;378(14):1323-1334. doi: 10.1056/NEJMra1402513. No abstract available.
- Background: PubMed 17177177Jelinic P, Shaw P. Loss of imprinting and cancer. J Pathol. 2007 Feb;211(3):261-8. doi: 10.1002/path.2116.
- Background: PubMed 26056362Haig D. Maternal-fetal conflict, genomic imprinting and mammalian vulnerabilities to cancer. Philos Trans R Soc Lond B Biol Sci. 2015 Jul 19;370(1673):20140178. doi: 10.1098/rstb.2014.0178.
- Background: PubMed 29302578Nilendu P, Sharma NK. Epigenomic Hard Drive Imprinting: A Hidden Code Beyond the Biological Death of Cancer Patients. J Cancer Prev. 2017 Dec;22(4):211-218. doi: 10.15430/JCP.2017.22.4.211. Epub 2017 Dec 30.
- Background: PubMed 21262060Uribe-Lewis S, Woodfine K, Stojic L, Murrell A. Molecular mechanisms of genomic imprinting and clinical implications for cancer. Expert Rev Mol Med. 2011 Jan 25;13:e2. doi: 10.1017/S1462399410001717.
- 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. 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 Early Diagnosis and Cancer, run by Chinese Alliance Against Lung Cancer 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 4 inclusion and 6 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 20 Mar 2019. 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 Chunxue Bai, MD (18621170011, bai.chunxue@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of imprinting cancer early detection (time frame: In the middle of the study, an average of 15 months). The study lists 2 primary outcomes in all. 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 NCT03882684, which also lists 5 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 20 Mar 2019.