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clinical trials

Breast Cancer Phase III trial

ICRG 1201

Multicentre, International 3rd Generation neoadjuvant randomized double-blind trial comparing Fulvestrant® to a combination of Fulvestrant® and Palbociclib (CDK 4/6 Inhibitor) in patients with operable luminal breast cancer responding to Fulvestrant.

Sponsor: ICRG
Partnership with AstraZeneca, Pfizer and Genomic Health
Clinical Phase: Phase 3
Sample size: 400 subjects. Closed August 2020.
Participating countries: Kingdom of Saudi Arabia, Algeria, Egypt, Jordan, Tunisia, Lebanon.
Total of 24 study sites
Link: Click Here

Cancer screening and early diagnosis

an horizontal approach

ICRG 1201 [b]

Multicentre, International neoadjuvant randomized double-blind trial comparing Fulvestrant® to a combination of Fulvestrant® and Palbociclib (CDK 4/6 Inhibitor) in patients with operable luminal breast cancer responding to Fulvestrant: Pilot study of the prediction of therapy efficacy by liquid biopsies using infrared field-resolved laser spectroscopy (Quantum Optics) and Artificial Intelligence (AI).

Sponsor: ICRG
Partnership with: LMU/MPQ, KAUST, and KSU
Sample size: 100 subjects. Closed August 2020.

KSU-ICRG 0100

"Proof of concept" study: evaluation on liquid biopsies of infrared field-resolved laser spectroscopy (Quantum Optics ) combined with an Artificial Intelligence(AI) approach for breast cancer detection.

Sponsor: KSU/ICRG
Partnership with: LMU/MPQ, KAUST, and KSU
Clinical phase: Prospective Case-Control, non-randomized, open study.
Sample size: 100 subjects. Closed. Results reported at the 2019 ESMO meeting (Barcelona) / Ann. Oncol. Final manuscript to peer-reviewed journal at the submission phase.
Study site: Oncology Centre, King Saud University Medical City, KSA

ICRG 0101

Multicentric large scale validation study of the infrared field-resolved laser spectroscopy (Femto/attosecond technology) on liquid biopsies in breast cancer screening

Sponsor: King Saud University (KSU) - International Cancer Research Group (ICRG)
Clinical phase: Prospective Case-Control, non-randomized, open, validation study.
Sample size: 1100 subjects (patients and healthy controls). Open for accrual.
Participating country: France, 5 study sites.
Promotor: Jean Perrin Cancer Centre of Auvergne

KSU-ICRG 0103

Multicentric "proof of concept" study: evaluation of infrared field-resolved laser spectroscopy of liquid biopsies for cancer detection.

Sponsor: King Saud University (KSU) - International Cancer Research Group (ICRG)
Clinical phase: Prospective Case-Control, non-randomized, open study.
Sample Size: 1200 subjects (patients and healthy controls). Open for accrual.
Participating countries: Kingdom of Saudi Arabia, Algeria, Egypt
Total of 13 study sites

ICRG 2101 [b]

A pilot multicenter exploratory study of the feasibility of DNA methylation analysis in liquid biopsies for breast cancer detection.

Sponsor: International Cancer Research Group (ICRG)- KSU) - KAUST
Clinical phase: Prospective Case-Control, non-randomized, open study.
Sample Size: 100 subjects (patients and healthy controls). Closed.
Participating countries: Kingdom of Saudi Arabia,

ICRG 2102

A pilot multicenter exploratory study of the feasibility of Quantum Optics technology by femtosecond infrared laser spectroscopy, dubbed BIRD: Broadband Infrared Diagnostics in colon cancer detection.

Sponsor: International Cancer Research Group (ICRG)- KSU - KAUST
Clinical phase: Prospective Case-Control, non-randomized, open study.
Sample Size: 200 subjects (patients and healthy controls). Open for accrual.
Participating countries: Kingdom of Saudi Arabia, Algeria.

ICRG 2102 [b]

A pilot multicenter exploratory study of the feasibility of DNA methylation analysis in liquid biopsies for colon cancer detection.

Sponsor: International Cancer Research Group (ICRG)- KSU) - KAUST
Clinical phase: Prospective Case-Control, non-randomized, open study.
Sample Size: 100 subjects (patients and healthy controls). Open for accrual.
Participating countries: Kingdom of Saudi Arabia, Algeria.

ICRG 2103

A pilot multicenter exploratory study of the feasibility of Quantum Optics technology by femtosecond infrared laser spectroscopy, dubbed BIRD: Broadband Infrared Diagnostics in lung cancer detection.

Sponsor: International Cancer Research Group (ICRG)- KSU) - KAUST
Clinical phase: Prospective Case-Control, non-randomized, open study.
Sample Size: 200 subjects (patients and healthy controls). Open for accrual.
Participating countries: Kingdom of Saudi Arabia,

ICRG 2103 [b]

A pilot multicenter exploratory study of the feasibility of DNA methylation analysis in liquid biopsies for lung cancer detection.

Sponsor: International Cancer Research Group (ICRG)- KSU) - KAUST
Clinical phase: Prospective Case-Control, non-randomized, open study.
Sample Size: 100 subjects (patients and healthy controls). Open for accrual.
Participating countries: Kingdom of Saudi Arabia,

ICRG 2104

A pilot multicenter exploratory study of the feasibility of Quantum Optics technology by femtosecond infrared laser spectroscopy, dubbed BIRD: Broadband Infrared Diagnostics in pancreas cancer detection.

Sponsor: International Cancer Research Group (ICRG)- KSU) - KAUST
Clinical phase: Prospective Case-Control, non-randomized, open study.
Sample Size: 200 subjects (patients and healthy controls). Open for accrual.
Participating countries: Kingdom of Saudi Arabia,

ICRG 2104 [b]

A pilot multicenter exploratory study of the feasibility of DNA methylation analysis in liquid biopsies for pancreas cancer detection.

Sponsor: International Cancer Research Group (ICRG)- KSU) - KAUST
Clinical phase: Prospective Case-Control, non-randomized, open study.
Sample Size: 100 subjects (patients and healthy controls). Open for accrual.
Participating countries: Kingdom of Saudi Arabia,

ICRG 2105

A pilot multicenter exploratory study of the feasibility of Quantum Optics technology by femtosecond infrared laser spectroscopy, dubbed BIRD: Broadband Infrared Diagnostics in stomach cancer detection.

Sponsor: International Cancer Research Group (ICRG)- KSU) - KAUST
Clinical phase: Prospective Case-Control, non-randomized, open study.
Sample Size: 200 subjects (patients and healthy controls). Open for accrual.
Participating countries: Kingdom of Saudi Arabia,

ICRG 2105 [b]

A pilot multicenter exploratory study of the feasibility of DNA methylation analysis in liquid biopsies for stomach cancer detection.

Sponsor: International Cancer Research Group (ICRG)- KSU) - KAUST
Clinical phase: Prospective Case-Control, non-randomized, open study.
Sample Size: 100 subjects (patients and healthy controls). Open for accrual.
Participating countries: Kingdom of Saudi Arabia,

ICRG 2106

A pilot multicenter exploratory study of the feasibility of Quantum Optics technology by femtosecond infrared laser spectroscopy, dubbed BIRD: Broadband Infrared Diagnostics in ovarian cancer detection.

Sponsor: International Cancer Research Group (ICRG)- KSU) - KAUST
Clinical phase: Prospective Case-Control, non-randomized, open study.
Participating countries: Kingdom of Saudi Arabia,
Sample Size: 200 subjects (patients and healthy controls). Open for accrual.

ICRG 2106 [b]

A pilot multicenter exploratory study of the feasibility of DNA methylation analysis in liquid biopsies for ovarian cancer detection.

Sponsor: International Cancer Research Group (ICRG)- KSU) - KAUST
Clinical phase: Prospective Case-Control, non-randomized, open study.
Sample Size: 100 subjects (patients and healthy controls). Open for accrual.
Participating countries: Kingdom of Saudi Arabia,

ICRG 2107

A pilot multicenter exploratory study of the feasibility of Quantum Optics technology by femtosecond infrared laser spectroscopy, dubbed BIRD: Broadband Infrared Diagnostics in prostate cancer detection.

Sponsor: International Cancer Research Group (ICRG)- KSU) - KAUST
Clinical phase: Prospective Case-Control, non-randomized, open study.
Sample Size: 200 subjects (patients and healthy controls). Open for accrual.
Participating countries: Kingdom of Saudi Arabia,

ICRG 2107 [b]

A pilot multicenter exploratory study of the feasibility of DNA methylation analysis in liquid biopsies for prostate cancer detection.

Sponsor: International Cancer Research Group (ICRG)- KSU) - KAUST
Clinical phase: Prospective Case-Control, non-randomized, open study.
Sample Size: 100 subjects (patients and healthy controls). Open for accrual.
Participating countries: Kingdom of Saudi Arabia,

ICRG 0201

Multicenter, international first-line metastatic open-label prospective phase II trial evaluating the combination of Palbociclib (CDK 4/6 Inhibitor) and hormone therapy (Letrozole or Anastrozole) in women with luminal, HER negative advanced breast cancer: Evaluation of the prediction of individual treatment efficacy using infrared laser spectroscopy analysis on liquid biopsies (Quantum Optics).

Sponsor: ICRG
Partnership: LMU/MPQ, KAUST
Clinical phase: Phase 2, Sample size: 80 patients.
Participating countries: Kingdom of Saudi Arabia, Algeria, Egypt, Jordan.
Total 6-10 study sites
Study in preparation.

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Version: 2.0.0 - Last updated: 06-09-2021