OrganoidsNCT03577808
Organoids in Predicting Chemoradiation Sensitivity on Rectal Cancer
An observational study of Organoids and Rectal Cancer, run by Zhen Zhang at 1 site in China.
Trial summary
Patients with locally advanced rectal cancer will receive biopsy before the standard treatment of neoadjuvant chemoradiation. The investigators are going to establish organoids model from the pre-treatment biopsies and expose organoids to irradiation and the same chemotherapy drugs. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Organoids, Rectal Cancer, Chemoradiation
- What is being tested?
- Biopsy
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 17 Aug 2018to 1 Nov 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 to 75 years
- All sexes
- Adult, Older adult
Study population: Patients with locally advanced rectal cancer will receive neoadjuvant chemoradiation. The radiation procedure and concurrent chemotherapy drugs will base on clinical practice.
Who may be able to join
- pathological confirmed adenocarcinoma
- clinical stage T3-4 and/or N+
- the distance from anal verge less than 12 cm
- without distance metastases
- KPS >=70
- without previous anti-cancer therapy
- sign the inform consent
Who cannot join
- pregnancy or breast-feeding women
- serious medical illness
- baseline blood and biochemical indicators do not meet the following criteria: neutrophils≥1.5×10^9/L, Hb≥90g/L, PLT≥100×10^9/L, ALT/AST ≤2.5 ULN, Cr≤ 1 ULN
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fudan University
Shanghai
Lijun Shen, MD, 86-2164175590, lijunshen@fudan.edu.cn
Zhen Zhang, MD, 86-2164175590, zhen_zhang@fudan.edu.cn
About this study
Official title: Validation of Organoids Potential Use as a Companion Diagnostic in Predicting Neoadjuvant Chemoradiation Sensitivity in Locally Advanced Rectal Cancer
Patients with locally advanced rectal cancer will receive biopsy before the standard treatment of neoadjuvant chemoradiation. The investigators are going to establish organoids model from the pre-treatment biopsies and expose organoids to irradiation and the same chemotherapy drugs. The sensitivity of irradiation and chemotherapy drugs will be tested in the organoids model. Here, the investigators will launch the observational clinical trial to validate whether the organoids could predict the clinical outcome in locally advanced rectal cancer patients underwent neoadjuvant chemoradiation.
- Conditions
- Organoids, Rectal Cancer, Chemoradiation
- Being tested
- Biopsy
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiopsyOther
Patients with locally advanced rectal cancer will receive biopsy of the primary tumor before neoadjuvant chemoradiation.
| Study group | Role | What they receive |
|---|---|---|
| Arm | Patients with locally advanced rectal cancer will receive neoadjuvant chemoradiation. The radiation procedure and concurrent chemotherapy drugs will base on clinical practice. Organoids bio-bank of pre-treatment tumor biopsies will be established and exposed to irradiation and the same chemotherapy drugs as the corresponding patient. Receives: Other: Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response of the rectal cancer organoids to irradiation and the same chemotherapy drugs as the corresponding patient.
The investigators will culture rectal cancer organoids and treat with irradiation and the same chemotherapy drugs as the corresponding patient. The number and size of alive organoids will be observed after treatment. The correlation of organoids sensitivity and patient response will be evaluated.
Measured: 2018.08-2020.11
Secondary outcomes (1)
Response of the rectal cancer patients to neoadjuvant chemoradiation.
The investigators will use pathological tumor regression grade (TRG) to evaluate chemoradiation response of locally advanced rectal cancer patients.
Measured: 2018.08-2020.11
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2018
- Study start17 Aug 2018
- Primary completion1 Aug 2020 (estimated)
- Study completion1 Nov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OrganoidsStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhen Zhang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhen Zhang, Fudan University
- Investigators
- Zhen Zhang, MD, Principal investigator, Fudan UniversityGuoqiang Hua, PhD, Principal investigator, Institute of Radiation Medicine, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03577808
- Sponsor's protocol ID
- FDRT-R008
- Status last verified
- Aug 2018
- First submitted
- 20 Jun 2018
- Last updated
- 20 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Organoids Potential Use as a Companion Diagnostic in Predicting Neoadjuvant Chemoradiation Sensitivity in Locally Advanced Rectal Cancer
- ClinicalTrials.gov ID
- NCT03577808
- Acronym / sponsor ID
- FDRT-R008
- Conditions
- Organoids, Rectal Cancer, Chemoradiation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Zhen ZhangUniversity, hospital or other
- Study start
- 17 Aug 2018 (actual)
- Primary completion
- 1 Aug 2020 (estimated)
- Study completion
- 1 Nov 2020 (estimated)
- First posted
- 5 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.
Patients with locally advanced rectal cancer will receive biopsy before the standard treatment of neoadjuvant chemoradiation. The investigators are going to establish organoids model from the pre-treatment biopsies and expose organoids to irradiation and the same chemotherapy drugs. The sensitivity of irradiation and chemotherapy drugs will be tested in the organoids model. Here, the investigators will launch the observational clinical trial to validate whether the organoids could predict the clinical outcome in locally advanced rectal cancer patients underwent neoadjuvant chemoradiation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm | – | Other: BiopsyPatients with locally advanced rectal cancer will receive neoadjuvant chemoradiation. The radiation procedure and concurrent chemotherapy drugs will base on clinical practice. Organoids bio-bank of pre-treatment tumor biopsies will be established and exposed to irradiation and the same chemotherapy drugs as the corresponding patient. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with locally advanced rectal cancer will receive neoadjuvant chemoradiation. The radiation procedure and concurrent chemotherapy drugs will base on clinical practice.
Key inclusion criteria (7 listed)
- pathological confirmed adenocarcinoma
- clinical stage T3-4 and/or N+
- the distance from anal verge less than 12 cm
- without distance metastases
- KPS >=70
Key exclusion criteria (3 listed)
- pregnancy or breast-feeding women
- serious medical illness
- baseline blood and biochemical indicators do not meet the following criteria: neutrophils≥1.5×10^9/L, Hb≥90g/L, PLT≥100×10^9/L, ALT/AST ≤2.5 ULN, Cr≤ 1 ULN
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 |
|---|---|---|
| BiopsyPatients with locally advanced rectal cancer will receive biopsy of the primary tumor before neoadjuvant chemoradiation. | Other | Arm |
Primary outcome
Response of the rectal cancer organoids to irradiation and the same chemotherapy drugs as the corresponding patient.
Time frame: 2018.08-2020.11
The investigators will culture rectal cancer organoids and treat with irradiation and the same chemotherapy drugs as the corresponding patient. The number and size of alive organoids will be observed after treatment. The correlation of organoids sensitivity and patient response will be evaluated.
1 secondary outcome
Response of the rectal cancer patients to neoadjuvant chemoradiation.
Time frame: 2018.08-2020.11
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2018.
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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.
Zhen Zhang, MD principal investigator
Fudan University
Guoqiang Hua, PhD principal investigator
Institute of Radiation Medicine, Fudan University
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 Organoids and Rectal Cancer, run by Zhen Zhang 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 7 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 20 Aug 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 Lijun Shen, MD (86-2164175590, lijunshen@fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response of the rectal cancer organoids to irradiation and the same chemotherapy drugs as the corresponding patient. (time frame: 2018.08-2020.11). 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 20 Aug 2018.