Several clinical trials evaluate indications across oncology, surgical care, and psychiatric disorders, focusing on Stage I–IV uterine corpus carcinoma, recurrent endometrial malignancies, Lynch syndrome, colorectal surgical health practice, and adolescent post-traumatic stress disorder. Sponsored by institutions such as the National Cancer Institute, the Gynecologic Oncology Group, the University of Alabama at Birmingham, and the University of California, Los Angeles, these studies encompass Phase 2, non-interventional, and unclassified trial phases. Investigating genomic alterations like topoisomerase 2-alpha, endometrial research programs, and post-traumatic stress therapies, all registered trials currently maintain a recruitment status of not yet recruiting.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT01199250 | Not yet recruiting | Lynch Syndrome|Recurrent Uterine Corpus Carcinoma|Stage I Uterine Corpus Cancer|Stage II Uterine Corpus Cancer|Stage III Uterine Corpus Cancer|Stage IV Uterine Corpus Cancer |
Gynecologic Oncology Group|National Cancer Institute (NCI)|GOG Foundation |
2100-01 | -- |
| NCT01164735 | Not yet recruiting | Recurrent Uterine Corpus Carcinoma|Stage III Uterine Corpus Cancer|Stage IV Uterine Corpus Cancer |
Gynecologic Oncology Group|National Cancer Institute (NCI)|GOG Foundation |
2100-01 | -- |
| NCT06356558 | Not yet recruiting | Surgery|Health Knowledge Attitudes Practice|Colorectal Disorders |
University of Alabama at Birmingham|National Cancer Institute (NCI) |
2026-05 | Not Applicable |
| NCT06353282 | Not yet recruiting | PTSD Post Traumatic Stress Disorder|Adolescents|Psychotherapy |
University of California Los Angeles |
2025-07-01 | Phase 2 |
(data from https://clinicaltrials.gov, updated on 2024-05-22)
Mechanism and Biochemical Profile
Appendix RUO and cGMP Quality Standards
| Quality Dimension | RUO (Research Use Only) | cGMP (Current Good Manufacturing Practice) |
|---|---|---|
| Clinical Applicability | Prohibited in human clinical trials or medical diagnostics. | Mandatory for human clinical trials (Phase I–III) and therapies. |
| Regulatory Status | Non-regulated grade; exempt from drug manufacturing laws. | Legally enforced by health authorities (e.g., FDA, EMA, NMPA). |
| Facility Environment | Unclassified analytical or research laboratories. | Validated Cleanrooms (ISO Class 5–8) with continuous monitoring. |
| Quality Control | Basic purity and activity testing. | Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma). |
| Process Validation | Basic equipment calibration; no process validation required. | Full qualification (IQ/OQ/PQ) and complete batch records. |
| Quality Assurance | Vendor self-declared without required formal QMS. | Mandatory QA/QC unit, Change Control, CAPA, and vendor audits. |
| Regulatory Impact | High risk of IND rejection if used as a critical raw material. | Required for IND/NDA filings, supported by Drug Master Files (DMF). |
Footnotes
Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).